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The study did not reach 50% of the proposed sample size. Recruitment slow because persons not interested in being randomized to a sham-control CPAP device or not CPAP naïve.
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Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.
While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied.
The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM.
Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CPAP treatment | Experimental | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) |
|
| Sham-CPAP | Placebo Comparator | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C Level | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. | baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine Level | Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00. | baseline, 6 weeks, 12 weeks |
| Diabetes Diet Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen R. Chasens, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John D. Dingell VAMC | Detroit | Michigan | 48201 | United States | ||
| Pittsburgh Veterans Administration Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34105104 | Derived | Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9. | |
| 30517889 | Derived | Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2. |
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Phone assessment excluded persons with prior CPAP use, not having diagnosis of type 2 diabetes, history of a sleepiness related accident or near miss, or not ambulatory.
Participants (n=355) who met the phone screening were invited for a baseline assessment. The baseline assessment excluded persons with HbA1c either < 6.5% or > 11%; without OSA, with too high a AHI or severe oxygen desaturations, or not interested in being randomized to sham-CPAP. 98 participants meet all eligibility criteria.
Participants recruitment started in 2014 and the last participant was evaluated in 2019. The total sample screened (N=862) was from the University of Pittsburgh (n=720), Veterans Administration Pittsburgh Healthcare System (n=58), West Virginial University (n=72), and the John Dingell Detroit Veterans Administration Healthcare System (n=12).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active CPAP Treatment | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| FG001 | Sham-CPAP | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization But Not Titrated |
|
| |||||||||||||||||||||
| Started Protocol to Week 6 |
| ||||||||||||||||||||||
| Week 12 Assessment |
| ||||||||||||||||||||||
| Week 24 |
| ||||||||||||||||||||||
| Week 36 |
|
Participants who were initially approved by primary care provider to engage in study with type 2 diabetes, an HbA1c 6.5% to 11.0%, age 18 years or older, apnea-hypopnea index >= 10/hr., denied excessive alcohol consumption, denied car crash or near accident, denied previous CPAP use, denied being pregnant or negative test if potentially pregnant, and willing to be randomized to participate in study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active CPAP Treatment | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| 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 | HbA1C Level | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | % of glycated hemoglobin in the blood | baseline, 6 weeks, 12 weeks |
|
Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
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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 | Active CPAP Treatment | Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in knees bilateral | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Hospitalization for 2 days for septic arthritis of knees bilaterally--unrelated to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| difficulty wearing mask | Product Issues | Systematic Assessment | Complains of claustrophobia feelings while wearing the mask |
Recruitment was negatively affected by a large number of persons screened who were ineligible because of either their, or a family member, having prior CPAP treatment. Recruitment was also affected by persons who did not want the possibility of being randomized to be on a sham-CPAP device for 12 weeks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen R. Chasens, PhD, Professor of Nursing | University of Pittsburgh | 412-624-9380 | chasense@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2018 | Jun 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
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|
|
| Sham-CPAP | Device | Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). |
|
|
| Diabetes Education | Behavioral | Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
|
Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet
| baseline, 6 weeks, 12 weeks |
| Diabetes Knowledge | Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks) | baseline,12 weeks only |
| Self-Monitoring of Blood Glucose (SMBG) | SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG | baseline, 6 weeks, 12 weeks |
| Steps Walked | Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00. | baseline, 6 weeks, 12 weeks |
| Self-Monitoring of Foot Care | Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care | baseline, 6 weeks, 12 weeks |
| Diabetes-Related Distress | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. | baseline, 6 weeks, 12 weeks |
| Sleep Quality | Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality. | baseline, 6 weeks, 12 weeks |
| Mood | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. | baseline, 6 weeks, 12 weeks |
| Vigilance | Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance. | Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session |
| Pittsburgh |
| Pennsylvania |
| 15240 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| NOT COMPLETED |
|
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
|
| BG001 | Sham-CPAP | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Percentage of the number of hemoglobin molecules on red blood cells that are glycated. HbA1c indicates overall glucose control over last 3 months. Reference range for adults without diabetes is 4-5.9%. | Mean | Standard Deviation | percentage of glycated hemoglobins |
|
| Fructosamine | Glucose molecules permanently combined with albumin proteins in the blood, fructosamine indicates the average level of blood glucose control over the past 2-3 weeks. Normal range in persons without diabetes is is 200-285 µmol/L. | This measure was not done by protocol at University of West Virginia and Detroit VA; missing data at Pitt and VAPHS | Mean | Standard Deviation | µmol/L |
|
| Body Mass Index (kg/m^2) | Obtained by measured height and weight. | Mean | Standard Deviation | kg/m^2 |
|
| Apnea-Hypopnea Index | Mean number of apneas (cessation of breathing) and hypopneas (reduction in airflow by at least 50%) during overnight home sleep study with portable device that measures nasal airflow, chest and abdominal movement, oximetry, EKG. | Mean | Standard Deviation | events per hour of sleep |
|
| Epworth Sleepiness Scale | Validated instrument to measure subjective sleepiness. Scores potentially range from 0 to 24 with higher scores indicating more sleepiness. | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Index Total Score | The Pittsburgh Sleep Quality Index (PSQI) is a validated measure of dimensions of sleep quality. Higher scores indicate worse sleep quality; potential range is 0 to 27 with scores greater than 5 indicating poor sleep quality. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Fructosamine Level | Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00. | All randomized participants with data were analyzed (the intention to treat method). Unable to obtain laboratory value on from participants from West Virginia University (n=12), Detroit (n=1), and Pitt (n=2) | Posted | Mean | Standard Error | umol/L (micromols per liter) | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Diabetes Diet Adherence | Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet | All randomized participants with valid data were analyzed (the intention to treat method). One participant with missing data. | Posted | Mean | Standard Error | Average number of days/week | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Diabetes Knowledge | Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks) | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | % of correct answers | baseline,12 weeks only |
|
|
|
|
| Secondary | Self-Monitoring of Blood Glucose (SMBG) | SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | Average number of days/week | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Steps Walked | Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00. | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | Steps/day | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Self-Monitoring of Foot Care | Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | Average number of days/week | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Diabetes-Related Distress | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Sleep Quality | Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality. | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| Secondary | Mood | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. | All randomized participants were analyzed (the intention to treat method). | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
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|
|
| Secondary | Vigilance | Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance. | All randomized participants with data were were analyzed (the intention to treat method). This measure was not done per site protocol at West Virginia (n=12) and Detroit (n=1)), missing data from participants at Pittsburgh and VA Pittsburgh sites (n=29). | Posted | Mean | Standard Error | transformed lapses | Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session |
|
|
|
|
| 0 |
| 49 |
| 1 |
| 49 |
| 0 |
| 49 |
| EG001 | Sham-CPAP | Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing). Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each) | 0 | 49 | 1 | 49 | 2 | 49 |
| EG002 | Active CPAP Following Sham-CPAP | Persons who completed 12-weeks on sham-CPAP, were debriefed, titrated for active CPAP | 0 | 20 | 0 | 20 | 0 | 20 |
|
| Diagnosed with lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated to study but discharged from study |
|
| Hypertension | Cardiac disorders | Systematic Assessment | Participant hospitalized for 2 days with hypertension. |
|
|
Not provided
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| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 12-week |
|
| 12-week |
|
| 6-week |
|
|
| 12-week |
|
|
| 12-week |
|
| 6-week |
|
|
| 12-week |
|
|
| 6-week |
|
|
| 12-week |
|
|
| 12-week |
|
| 12-week |
|
| Average lapses 2nd Diabetes Education Session |
|