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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease.
A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups:
Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either:
Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist.
Conservative Medical Therapy Group (CMT)*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator.
A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease.
This is a 6-12 month study** to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those features that would strengthen a later, large-scale randomized controlled trial.
We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and mortality.
*All randomized participants will be given conservative medical therapy (CMT).
**For those randomized after December 31, 2012, follow-up assessment will only be 6 months long
In this pilot randomized controlled trial, we will assess the effectiveness of CPAP therapy to reduce the burden of cardiovascular disease (CVD) and CVD risk factors in patients with moderate to severe obstructive sleep apnea (OSA) presenting to a sleep disorders clinic. A total of 700 patients with a new diagnosis of moderate to severe OSA will be recruited from BWH-affiliated sleep disorder clinics, BWH, Massachusetts General Hospital (MGH), and Faulkner Hospital Cardiology Clinics (and similar specialized clinics seeing patients with cardiovascular risk factors, such as endocrinology and hypertensive clinics), Beth Israel Deaconess Medical Center and Joslin Diabetes Center. After completing a 2 week run-in period, randomized participants (approximately 150 participants will be randomized) will undergo baseline and 6 month assessments of key study exposure and outcome variables.
Participants will be randomized after completion of Baseline visit. The treatment arms are as follows:
The active arms are:
The control arms are:
Participants randomized before December 31, 2012 (n=108) also will undergo 12 month follow-up assessments. Participants will be offered a 12 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 and 12 months, study outcomes will be reassessed by collecting data from sources.
Patients randomized after December 31, 2012 (n=61) will undergo only 6 months of follow-up assessment. Participants will be offered a 6 month supervised conservative medical therapy (CMT) program for OSA over the duration of the study intervention. Subjects would be contacted at bimonthly intervals by alternating phone and office visits to assess safety, identify adverse events, identify health care utilization, and reinforce protocol adherence. At 6 months, study outcomes will be reassessed by collecting data from sources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Medical Therapy (CMT) | Placebo Comparator | All participants will meet with a research assistant who will provide ~30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breath Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. |
|
| Sham PAP (Sham) | Sham Comparator | In addition to receiving CMT, participants in this treatment arm will receive a sham-CPAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active PAP arms. The treatment visit schedule is outlined below.
It is estimated that each in-person follow-up adherence visit with the PAP specialist would last ~30 minutes. |
|
| Active PAP with RT Support (Active-Beh) | Active Comparator | In addition to receiving CMT, participants will receive active-PAP. The treatment visit schedule is outlined below.
All visits will take place with a PAP specialist. All follow-up visits will be anchored to the initial PAP set-up visit. At these visits, using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. Each follow-up visit with the PAP specialist will last 30 minutes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative Medical Therapy (CMT) | Behavioral | All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. | Mean of 6- and 12-months |
| Difference in CPAP Adherence by Active Treatment Arm | Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization. | 6-months |
| Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months. | Mean of 6- and 12-months |
| Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. | 12-months |
| Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
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Inclusion Criteria:
Obstructive apnea hypopnea index (AHI) ≥ 15
Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.
Established CVD,or having diabetes mellitus, defined by one or more of the following:
OR
Three or more of the following established CVD risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Redline, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Murray Mittleman, MD, DrPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35459446 | Derived | Zhao YY, Wang R, Gleason KJ, Lewis EF, Quan SF, Toth CM, Song Y, Morrical M, Rueschman M, Mittleman MA, Redline S. Effect of continuous positive airway pressure treatment on ambulatory blood pressures in high-risk sleep apnea patients: a randomized controlled trial. J Clin Sleep Med. 2022 Aug 1;18(8):1899-1907. doi: 10.5664/jcsm.10012. | |
| 31116848 |
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Patients with no sleep study were provided a portable sleep monitor to measure the severity (if any) of obstructive sleep apnea (OSA). If tests shows moderate to severe OSA, patients were asked to wear a positive airway pressure (PAP) mask with no pressure for 2 weeks. Those with proven adherence during this time were scheduled for a baseline visit
Initial recruitment was limited to patients with sleep apnea identified through clinical sleep programs of Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Recruitment later expanded to include patients presenting to cardiology and diabetes clinics. Recruitment began on April 2011 and ended on June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conservative Medical Therapy (CMT) | All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. |
| FG001 | Sham PAP (Sham) | In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms. |
| FG002 | Active PAP With RT Support (Active-Beh) | In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes. |
| FG003 | Active PAP With Behavioral Modification (Active+Beh) | In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
If were not able to collect data from a participant (24-hour blood pressure monitor, echocardiogram, questionnaires, etc), we did not included them in the Baseline Analysis for that measure. This will result in different n-values for each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Conservative Medical Therapy (CMT) | All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. | Posted | Mean | Standard Deviation | mmHg | Mean of 6- and 12-months |
|
6 months to 1 year, depending on participant's randomization date.
Adverse events were reported to study coordinator during bimonthly phone assessments. Adverse events that were reported to other staff members on treatment visits (respiratory and/or behavioral therapist) or study visits were reported to the study coordinator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conservative Medical Therapy (CMT) | All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Redline | Brigham and Women's Hospital | 617-732-5859 | sredline1@rics.bwh.harvard.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
| Active PAP with Behavioral Modification (Active+Beh) | Active Comparator | In addition to receiving CMT and active-PAP, participants will have behavioral intervention sessions to promote PAP adherence. The treatment visit schedule is outlined below: Visits with Behavioral Interventionist (in addition to active-PAP treatment visits):
All follow-up visits will be anchored to the initial PAP set-up visit. PAP treatment visits will occur as outlined in the active-PAP arm. All behavioral intervention visits will be 30-min phone calls, unless otherwise noted. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. |
|
|
|
| Sham PAP (Sham) | Device | In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms. |
|
|
| Active PAP with RT Support (Active-Beh) | Device | In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The CPAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes. |
|
|
| Active PAP with Behavioral Modification (Active+Beh) | Device | In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. |
|
|
| 6-months |
| Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months. | 12-months |
| Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months. | 6-months |
| Change in Epworth Sleepiness Scale (ESS) (4 Arm) | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Patient Health Questionnaire (PHQ8) (4 Arm) | The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Lipid Panel at 6 and 12 Months (4 Arm) | Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Change in Augmentation Index at Months 6 and 12 (4 Arms) | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Mean of 6- and 12-months |
| Left Ventricular (LV) Mass Index (4 Arm) - Baseline | Baseline Left Ventricular Mass Index measured via echocardiography. | 12-months |
| Left Atrial (LA) Volume Index (4 Arm) - Baseline | Baseline Left Atrial Mass Index measured via echocardiography. | 12-months |
| End-Diastolic Volume (4 Arm) - Baseline | Baseline End-Diastolic Volume measured via echocardiography. | 12-months |
| Ejection Fraction (4 Arm) - Baseline | Baseline Ejection Fraction measured via echocardiography. | 12-months |
| Right Ventricular Fractional Area Change (4 Arm) - Baseline | Baseline RV Fractional Area Change measured via echocardiography. | 12-months |
| Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. | 12-months |
| Pulmonary Vascular Resistance (4 Arm) - Baseline | Baseline Pulmonary Vascular Resistance measured via echocardiography. | 12-months |
| E/Em Lateral Ratio (4 Arm) - Baseline | Baseline E/Em Lateral Ratio measured via echocardiography. | 12-months |
| Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography. | 12-months |
| Left Ventricular Mass Index (4 Arm) - 12 Month | Endpoint Left Ventricular Mass Index measured via echocardiography. | 12-months |
| Left Atrial Volume Index (4 Arm) - 12 Month | Endpoint Left Atrial Volume Index measured via echocardiography. | 12-months |
| End-Diastolic Volume (4 Arm) - 12 Month | Endpoint End-Diastolic Volume measured via echocardiography. | 12-months |
| Ejection Fraction (4 Arm) - 12 Month | Endpoint Ejection Fraction measured via echocardiography. | 12-months |
| Right Ventricular Fractional Area Change (4 Arm) - 12 Month | Endpoint Right Ventricular Fractional Area Change measured via echocardiography. | 12-months |
| Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. | 12-months |
| Pulmonary Vascular Resistance (4 Arm) - 12 Month | Endpoint Pulmonary Vascular Resistance measured via echocardiography. | 12-months |
| E/Em Lateral Ratio (4 Arm) - 12 Month | Endpoint E/Em Lateral Ratio measured via echocardiography. | 12-months |
| Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography. | 12-months |
| Reid ML, Gleason KJ, Bakker JP, Wang R, Mittleman MA, Redline S. The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial. Sleep. 2019 Aug 1;42(8):zsz099. doi: 10.1093/sleep/zsz099. |
| 27018174 | Derived | Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24. |
| 26856225 | Derived | Yaggi HK, Mittleman MA, Bravata DM, Concato J, Ware J, Stoney CM, Redline S. Reducing cardiovascular risk through treatment of obstructive sleep apnea: 2 methodological approaches. Am Heart J. 2016 Feb;172:135-43. doi: 10.1016/j.ahj.2015.07.033. Epub 2015 Sep 11. |
| Dissatisfaction with Treatment |
|
| Relocation |
|
| Loss of Interest in the Study |
|
| Lost to Follow-up |
|
| BG001 | Sham PAP (Sham) | In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms. |
| BG002 | Active PAP With RT Support (Active-Beh) | In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes. |
| BG003 | Active PAP With Behavioral Modification (Active+Beh) | In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cardiovascular Disease (CVD) Status | Number | participants |
|
| Diagnostic Type | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| AHI | AHI is an index of sleep apnea severity that combines apneas and hypopneas. The AHI is expressed as the number of respiratory events per hour. | Mean | Standard Deviation | respiratory events per hour |
|
| Baseline Resting Blood Pressure Data by Arm | Mean | Standard Deviation | mmHg |
|
| Baseline 24-Hour Blood Pressure Data by Arm | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. | We were not able to collect 24-hour blood pressure data from all participants that completed a baseline visit. | Mean | Standard Deviation | mmHg |
|
| Baseline Laboratory Measures by Arm - Triglyceride and HDL | Mean | Standard Deviation | mg/dL |
|
| Baseline Laboratory Measures by Arm - CRP | We were not able to collect C-Reactive Protein (CRP) values from all participants that completed a baseline visit. | Mean | Standard Deviation | mg/L |
|
| Baseline Echocardiogram Measures by Arm - Pulse Wave Velocity | We were not able to collect pulse wave velocity values from all participants that completed a baseline visit. | Mean | Standard Deviation | m/s |
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| Baseline Echocardiogram Measures by Arm - Augmentation Index | We were not able to collect augmentation index values from all participants that completed a baseline visit. | Mean | Standard Deviation | percent of central pulse pressure |
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| Baseline Echocardiogram Measures by Arm - Ejection Fraction | We were not able to collect ejection fraction values from all participants that completed a baseline visit. | Mean | Standard Deviation | percent ejection fraction |
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| Baseline Quality of Life Measures by Arm - Short Form Health Survey (SF-36) | The SF-36 is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating the more disability. | We were not able to collect all values from all participants that completed a baseline visit. | Mean | Standard Deviation | units on a scale |
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| Baseline Quality of Life Measures by Arm - ESS | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. We were not able to collect all values from all participants that completed a baseline visit. The following n-values apply to the respective categories below. CMT, n=43; Sham, n=40; Active-Beh, n=40; Active+Beh, n=41; Total, n=164 | Mean | Standard Deviation | units on a scale |
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| Baseline Quality of Life Measures by Arm - PHQ-8 | The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 - 24, with higher scores indicating increasing severity of depression. | We were not able to collect all values from all participants that completed a baseline visit. | Mean | Standard Deviation | units on a scale |
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| Baseline Quality of Life Measures by Arm - SAQLI | The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. | We were not able to collect all values from all participants that completed a baseline visit. | Mean | Standard Deviation | units on a scale |
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| OG001 |
| Active Treatment Arms (Pooled) |
Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm. |
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| Primary | Difference in CPAP Adherence by Active Treatment Arm | Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization. | Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms). | Posted | Mean | Standard Deviation | hours/night | 6-months |
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| Primary | Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep. | Posted | Mean | Standard Deviation | mmHg | Mean of 6- and 12-months |
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| Primary | Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep. | Posted | Mean | Standard Deviation | mmHg | 12-months |
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| Primary | Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep. | Posted | Mean | Standard Deviation | mmHg | 6-months |
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| Primary | Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep. | Posted | Mean | Standard Deviation | mmHg | 12-months |
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| Primary | Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) | Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months. | Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep. | Posted | Mean | Standard Deviation | mmHg | 6-months |
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| Secondary | Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) | The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | units on a scale | Mean of 6- and 12-months |
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| Secondary | Change in Epworth Sleepiness Scale (ESS) (4 Arm) | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | units on a scale | Mean of 6- and 12-months |
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| Secondary | Change in Patient Health Questionnaire (PHQ8) (4 Arm) | The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | units on a scale | Mean of 6- and 12-months |
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| Secondary | Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) | The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | units on a scale | Mean of 6- and 12-months |
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| Secondary | Change in C-Reactive Protein at Months 6 and 12 (4 Arm) | C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mg/L | Mean of 6- and 12-months |
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| Secondary | Change in Lipid Panel at 6 and 12 Months (4 Arm) | Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mg/dL | Mean of 6- and 12-months |
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| Secondary | Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) | Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mg/dL | Mean of 6- and 12-months |
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| Secondary | Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) | Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percentage glycosylated hemoglobin | Mean of 6- and 12-months |
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| Secondary | Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) | Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | uIU/mL | Mean of 6- and 12-months |
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| Secondary | Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) | Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | pg/dL | Mean of 6- and 12-months |
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| Secondary | Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) | Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Mean of 6- and 12-months |
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| Secondary | Change in Urine Microalbumin at Months 6 and 12 (4 Arm) | Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | ug/mL | Mean of 6- and 12-months |
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| Secondary | Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) | Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | ug/mg | Mean of 6- and 12-months |
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| Secondary | Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) | Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | AU/mL | Mean of 6- and 12-months |
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| Secondary | Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | m/s | Mean of 6- and 12-months |
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| Secondary | Change in Augmentation Index at Months 6 and 12 (4 Arms) | Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percent of central pulse pressure | Mean of 6- and 12-months |
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| Secondary | Left Ventricular (LV) Mass Index (4 Arm) - Baseline | Baseline Left Ventricular Mass Index measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | g/m2 | 12-months |
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| Secondary | Left Atrial (LA) Volume Index (4 Arm) - Baseline | Baseline Left Atrial Mass Index measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | m/m2 | 12-months |
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| Secondary | End-Diastolic Volume (4 Arm) - Baseline | Baseline End-Diastolic Volume measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm | 12-months |
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| Secondary | Ejection Fraction (4 Arm) - Baseline | Baseline Ejection Fraction measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percent ejection fraction | 12-months |
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| Secondary | Right Ventricular Fractional Area Change (4 Arm) - Baseline | Baseline RV Fractional Area Change measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percentage change in RV area | 12-months |
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| Secondary | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline | Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm/sec | 12-months |
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| Secondary | Pulmonary Vascular Resistance (4 Arm) - Baseline | Baseline Pulmonary Vascular Resistance measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | Wood units | 12-months |
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| Secondary | E/Em Lateral Ratio (4 Arm) - Baseline | Baseline E/Em Lateral Ratio measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mitral velocity ratio (absolute units) | 12-months |
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| Secondary | Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline | Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm/sec | 12-months |
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| Secondary | Left Ventricular Mass Index (4 Arm) - 12 Month | Endpoint Left Ventricular Mass Index measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | g/m2 | 12-months |
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| Secondary | Left Atrial Volume Index (4 Arm) - 12 Month | Endpoint Left Atrial Volume Index measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | m/m2 | 12-months |
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| Secondary | End-Diastolic Volume (4 Arm) - 12 Month | Endpoint End-Diastolic Volume measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm | 12-months |
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| Secondary | Ejection Fraction (4 Arm) - 12 Month | Endpoint Ejection Fraction measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percentage ejection fraction | 12-months |
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| Secondary | Right Ventricular Fractional Area Change (4 Arm) - 12 Month | Endpoint Right Ventricular Fractional Area Change measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | percentage change in RV area | 12-months |
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| Secondary | Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month | Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm/sec | 12-months |
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| Secondary | Pulmonary Vascular Resistance (4 Arm) - 12 Month | Endpoint Pulmonary Vascular Resistance measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | Wood units | 12-months |
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| Secondary | E/Em Lateral Ratio (4 Arm) - 12 Month | Endpoint E/Em Lateral Ratio measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | mitral velocity ratio (absolute units) | 12-months |
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| Secondary | Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month | 12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography. | Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date). | Posted | Mean | Standard Deviation | cm/sec | 12-months |
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| 7 |
| 44 |
| 17 |
| 44 |
| EG001 | Sham PAP (Sham) | In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training. | 5 | 42 | 22 | 42 |
| EG002 | Active PAP With RT Support (Active-Beh) | In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms. | 2 | 42 | 16 | 42 |
| EG003 | Active PAP With Behavioral Modification (Active+Beh) | In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes. | 4 | 41 | 18 | 41 |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Visual Impairment | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspnoea | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cerebellar Ischemia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Thrombotic Stroke | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Breast Abscess | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dysponea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pneumonia Bacterial | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Aortic Dissection | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Presyncope | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dysponea | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dermatitis Allergic | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Urticaria | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Blood Glucose Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Prostate Cancer | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Precancerous Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Carpal Tunnel Decompression | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
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|
|
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| 24-hour Diastolic Blood Pressure |
|
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| 24-hour Mean Arterial Pressure |
|
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| Sleep Systolic Blood Pressure |
|
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| Sleep Diastolic Blood Pressure |
|
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| Sleep Mean Arterial Pressure |
|
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| Wake Systolic Blood Pressure |
|
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| Wake Diastolic Blood Pressure |
|
|
| Wake Mean Arterial Pressure |
|
|
| 24-hour Diastolic Blood Pressure |
|
|
| 24-hour Mean Arterial Pressure |
|
|
| Sleep Systolic Blood Pressure |
|
|
| Sleep Diastolic Blood Pressure |
|
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| Sleep Mean Arterial Pressure |
|
|
| Wake Systolic Blood Pressure |
|
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| Wake Diastolic Blood Pressure |
|
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| Wake Mean Arterial Pressure |
|
|
| 24-hour Diastolic Blood Pressure |
|
|
| 24-hour Mean Arterial Pressure |
|
|
| Sleep Systolic Blood Pressure |
|
|
| Sleep Diastolic Blood Pressure |
|
|
| Sleep Mean Arterial Pressure |
|
|
| Wake Systolic Blood Pressure |
|
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| Wake Diastolic Blood Pressure |
|
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| Wake Mean Arterial Pressure |
|
|
|
| 24-hour Diastolic Blood Pressure |
|
|
| 24-hour Mean Arterial Pressure |
|
|
| Sleep Systolic Blood Pressure |
|
|
| Sleep Diastolic Blood Pressure |
|
|
| Sleep Mean Arterial Pressure |
|
|
| Wake Systolic Blood Pressure |
|
|
| Wake Diastolic Blood Pressure |
|
|
| Wake Mean Arterial Pressure |
|
|
|
| 24-hour Diastolic Blood Pressure |
|
|
| 24-hour Mean Arterial Pressure |
|
|
| Sleep Systolic Blood Pressure |
|
|
| Sleep Diastolic Blood Pressure |
|
|
| Sleep Mean Arterial Pressure |
|
|
| Wake Systolic Blood Pressure |
|
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| Wake Diastolic Blood Pressure |
|
|
| Wake Mean Arterial Pressure |
|
|
|
| SF-36 Mental Component |
|
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| SF-36 Vitality Subscale |
|
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| SF-36 Physical Functioning |
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| SF-36 Bodily Pain |
|
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| SF-36 General Health Perceptions |
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| SF-36 Physical Role Functioning |
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| SF-36 Emotional Role Functioning |
|
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| SF-36 Social Role Functioning |
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| SF-36 Mental Health |
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| InCRP (excluding raw >10) |
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| HDL Cholesterol |
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| LDL Cholesterol |
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| Total Cholesterol |
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| VLDL Cholesterol |
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| Fibrinogen |
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| Urine Creatinine |
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| Serum Creatinine |
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| B-type Natriuretic Peptide (BNP) |
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