Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U34HL105285-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Indiana University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.
The proposed study is a randomized controlled trial among patients with transient ischemic attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2 (control:intervention) randomization scheme. Intervention patients with sleep apnea will receive either a standard CPAP treatment intervention or an enhanced protocol designed to increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) CPAP adherence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intervention group | Active Comparator | This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support. |
|
| Enhanced CPAP intervention | Active Comparator | This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support. |
|
| Usual Care | No Intervention | This group usual care after TIA/stroke and a sleep study at the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard CPAP Intervention | Device |
| ||
| Enhanced CPAP Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA IR Change From Baseline | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline and up to 12 months |
| CRP Change From Baseline | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline and up to 12 months |
| IL-6 Change From Baseline | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline and up to 12 months |
| Catecholamine Change From Baseline | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline and up to 12 months |
| Heart Rate Variability Change From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA IR Change From Baseline With CPAP Use | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henry Yaggi, MD,MPH | Yale University | Principal Investigator |
| Dawn M Bravata, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States | ||
| University of Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26811929 | Background | Koo BB, Bravata DM, Tobias LA, Mackey JS, Miech EJ, Matthias MS, Stahl SM, Sico JJ, Vaz Fragoso CA, Williams LS, Lampert R, Qin L, Yaggi HK. Observational Study of Obstructive Sleep Apnea in Wake-Up Stroke: The SLEEP TIGHT Study. Cerebrovasc Dis. 2016;41(5-6):233-41. doi: 10.1159/000440736. Epub 2016 Jan 27. | |
| 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. |
Not provided
Not provided
Resource sharing plan In compliance NIH recommendations, we affirm our commitment to share our final research data in a timely fashion for this proposed study with the scientific community. We intend this to occur no later than the time of acceptance for publication of the main findings from the final dataset. We will share all data from the funded research that can be shared without compromising individual subjects' rights and privacy, regardless of whether the data have been used for publication.
Not provided
Not provided
Not provided
Not provided
Three patients withdrew prior to randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Intervention Group | This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support. Standard CPAP Intervention |
| FG001 | Enhanced CPAP Intervention | This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support. Enhanced CPAP Intervention |
| FG002 | Usual Care | This group usual care after TIA/stroke and a sleep study at the end of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Intervention Group | This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support. Standard CPAP Intervention |
| BG001 | Enhanced CPAP Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | HOMA IR Change From Baseline | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.). The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis population. | Posted | Mean | Standard Deviation | HOMA-IR Index | Baseline and up to 12 months |
|
Adverse events were monitored through the 12 month follow up period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Intervention Group | This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support. Standard CPAP Intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Stroke | Nervous system disorders | Systematic Assessment | Recurrent stroke |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | General disorders | Non-systematic Assessment | falls |
A study design which compares the effectiveness of a diagnostic and treatment strategy to usual care may result in an underestimate of the efficacy and potency of CPAP on our outcomes. Not all patients in the intervention strategy had sleep apnea.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry Klar Yaggi, MD (PI) | Yale University School of medicine | 203-785-4163 | henry.yaggi@yale.edu |
Not provided
| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| D020521 | Stroke |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. |
| Baseline and up to 12 months |
| 24-H Systolic Blood Pressure Mean Change From Baseline | 24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline and up to 12 months |
| Flow-mediated Vasodilation Mean Change From Baseline | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| Carotid Intima-Medial Thickness Mean Change From Baseline | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| CPAP Adherence Rates Change From Baseline | CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period. | Baseline to up to 12 months |
| Baseline to up to 12 months |
| CRP Change From Baseline With CPAP Use | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| IL-6 Change From Baseline With CPAP Use | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. IL-6 is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| Catecholamine Change From Baseline With CPAP Use | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamines change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| Heart Rate Variability Change From Baseline With CPAP Use | Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | 24-H Mean Systolic Blood Pressure change is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | Baseline to up to 12 months |
| Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. The carotid intimal thickness measurement was obtained by averaging the distance between the lumen-intima interface and the media-adventitia interface obtained from 5 contiguous sites 1 mm apart. | Baseline to up to 12 months |
| Medication-adjusted 24-H SBP Change From Baseline | Change in medication-adjusted 24-hour SBP, which is calculated as [mean 24-hour SBP in mmHg] + [patient's DDD × (8.0 mmHg), was assessed between CPAP adherence groups. The change from baseline up until the final measurement (up to 12 months) was assessed.](streamdown:incomplete-link) | Baseline to up to 12 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Physician Decision |
|
| Lost to Follow-up |
|
This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.
Enhanced CPAP Intervention
| BG002 | Usual Care | This group usual care after TIA/stroke and a sleep study at the end of the study. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.
Enhanced CPAP Intervention
| OG002 | Usual Care | This group usual care after TIA/stroke and a sleep study at the end of the study. |
|
|
| Primary | CRP Change From Baseline | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | mg/dl | Baseline and up to 12 months |
|
|
|
| Primary | IL-6 Change From Baseline | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. Il-6 is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | pg/ml | Baseline and up to 12 months |
|
|
|
| Primary | Catecholamine Change From Baseline | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamine is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | pg/ml | Baseline and up to 12 months |
|
|
|
| Primary | Heart Rate Variability Change From Baseline | Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | milliseconds | Baseline and up to 12 months |
|
|
|
| Primary | 24-H Systolic Blood Pressure Mean Change From Baseline | 24-H Systolic Blood Pressure is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and up to 12 months |
|
|
|
| Primary | Flow-mediated Vasodilation Mean Change From Baseline | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | mm | Baseline to up to 12 months |
|
|
|
| Primary | Carotid Intima-Medial Thickness Mean Change From Baseline | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness mean change is one of the measures used to assess cardiovascular risk. The change from baseline up until the final measurement (up to 12 months) was assessed. | Intention to treat analysis. | Posted | Mean | Standard Deviation | mm | Baseline to up to 12 months |
|
|
|
| Primary | CPAP Adherence Rates Change From Baseline | CPAP adherence rates were calculated as hours of CPAP use per night. The change from baseline up until the final measurement (up to 12 months) was assessed. The Respironics M-series (now System One, Phillips Respironics, North Ryde, Australia) produced a record of the patient adherence (hours of use per night) throughout the duration of the follow up period. | The analysis population is a subset of patients in the standard and enhanced intervention arms that had a diagnosis of sleep apnea. | Posted | Mean | Standard Deviation | Hours per night | Baseline to up to 12 months |
|
|
|
| Secondary | HOMA IR Change From Baseline With CPAP Use | The homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR change is one of the measures used to assess cardiovascular risk. HOMA-IR Index (measured by calculating - fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.) To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | HOMA-IR Index | Baseline to up to 12 months |
|
|
|
| Secondary | CRP Change From Baseline With CPAP Use | C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. CRP is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | mg/dl | Baseline to up to 12 months |
|
|
|
| Secondary | IL-6 Change From Baseline With CPAP Use | IL-6 is a type of protein known as a cytokine, produced by cells of the immune system in response to an infection. IL-6 test results measure the amount of IL-6 circulating in the blood and are used as one sign of systemic inflammation. IL-6 is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | pg/ml | Baseline to up to 12 months |
|
|
|
| Secondary | Catecholamine Change From Baseline With CPAP Use | Catecholamine testing measures the amounts of catecholamines which are a group of similar substances/hormones released into the blood in response to physical or emotional stress. The primary catecholamines are dopamine, epinephrine (adrenaline), and norepinephrine. Catecholamines change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | pg/ml | Baseline to up to 12 months |
|
|
|
| Secondary | Heart Rate Variability Change From Baseline With CPAP Use | Heart rate variability (HRV) is the constant variation in milliseconds between heartbeats. HRV is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | milliseconds | Baseline to up to 12 months |
|
|
|
| Secondary | 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use | 24-H Mean Systolic Blood Pressure change is one of the measures used to assess cardiovascular risk- this was assessed multiple times and averaged across a in 24 hour time period. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | mmHg | Baseline to up to 12 months |
|
|
|
| Secondary | Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use | Flow-mediated vasodilation is performed when the brachial artery diameter is measured (in mm) during three conditions; baseline (after at least 10 min supine rest), during reactive hyperaemia (induced by inflation to 250 mmHg and then deflation of a sphygmomanometer cuff around the forearm) and finally after the administration of sublingual nitroglycerin. A linear array, high resolution ultrasound transducer is used to provide B-mode images of the target vessel, proximal to the forearm cuff. Flow-mediated vasodilation is one of the measures used to assess cardiovascular risk and the mean of the change in the multiple measurements was used at each time point. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | mm | Baseline to up to 12 months |
|
|
|
| Secondary | Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change | Carotid Intima-Medial Thickness are measurements of the mean values of Intima-media thickness (IMT) of carotid arteries. Caroid Intima-Medial Thickness change is one of the measures used to assess cardiovascular risk. To determine if CPAP use had an impact on cardiovascular risk, these measures were compared among CPAP usage groups. The change from baseline up until the final measurement (up to 12 months) was assessed. The carotid intimal thickness measurement was obtained by averaging the distance between the lumen-intima interface and the media-adventitia interface obtained from 5 contiguous sites 1 mm apart. | The analysis population comprises of those with a sleep apnea diagnosis from a valid sleep study and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | mm | Baseline to up to 12 months |
|
|
|
| Secondary | Medication-adjusted 24-H SBP Change From Baseline | Change in medication-adjusted 24-hour SBP, which is calculated as [mean 24-hour SBP in mmHg] + [patient's DDD × (8.0 mmHg), was assessed between CPAP adherence groups. The change from baseline up until the final measurement (up to 12 months) was assessed.](streamdown:incomplete-link) | The analysis population comprises of those with a sleep apnea diagnosis and is split into 3 categories of CPAP use where the treatment arms are combined. | Posted | Mean | Standard Deviation | mmHg | Baseline to up to 12 months |
|
|
|
| 0 |
| 86 |
| 3 |
| 86 |
| 2 |
| 86 |
| EG001 | Enhanced CPAP Intervention | This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support. Enhanced CPAP Intervention | 4 | 82 | 6 | 82 | 3 | 82 |
| EG002 | Usual Care | This group usual care after TIA/stroke and a sleep study at the end of the study. | 2 | 84 | 7 | 84 | 3 | 84 |
| acute MI | Cardiac disorders | Systematic Assessment | acute MI |
|
| Unstable angina hospitalization | Cardiac disorders | Systematic Assessment | Unstable angina hospitalization |
|
| Urgent coronary revascularization | Cardiac disorders | Systematic Assessment | coronary revascularization |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |