An interventional study of PAP Treatment and Sleep Education I in Sleep Apnea, Insufficient Sleep Syndrome and Sleep, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness.
In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB.
This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.
Both groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.
Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's enrollment of 561 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Additional Inclusion Criteria for randomization will be:
Exclusion Criteria:
Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.
Behavioral: PAP Treatment
Participants will attend four weekly sessions to receive education about strategies to improve sleep.
Behavioral: Sleep Education I
Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
Motivational enhancement plus participant self-monitoring of sleep.
Epworth Sleepiness Scale (ESS)
ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness.
Time frame: 3-months after randomization
Reactive Hyperemia Index
Reactive Hyperemia Index (RHI) is a measure of endothelial function assessed using peripheral arterial tonometry (PAT) with the EndoPAT device (Itamar Medical Ltd., Caesarea, Israel). The type of the measure is continuous and no specified minimum or maximum value. RHI values \>1.67 are considered normal, whereas RHI values ≤1.67 are considered abnormal, with higher RHI values indicating better endothelial function.
Time frame: 3-months after randomization
24-hours Ambulatory Blood Pressure
Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure will be calculated.
Time frame: 3-months after randomization
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a point scale of 1 to 7 from strongly disagree to strongly agree. The minimum possible score is 9 and highest score is 63. A higher score indicates more severe fatigue and impact on the person's activities.
Time frame: 3-months after randomization
Psychomotor Vigilance Test (PVT)
PVT is a performance measure of alertness and vigilance. Reaction time to a visual cue, delivered at random intervals varying from 2 to 10 seconds, is measured. The total number of lapses (reaction time \>500ms) during the 10 minute test will be used as a measure of objective alertness.
Time frame: 3-months after randomization
561 participants started the study and out of those 129 participants were randomized.
| Milestone | PAP Treatment | Sleep Education I |
|---|---|---|
| Started | 67 | 62 |
| Completed | 67 | 62 |
| Not completed | 0 | 0 |
ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness.
| units on a scale | PAP Treatment | Sleep Education I |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | 9.03 ± 4.39 | 8.10 ± 4.87 |
Reactive Hyperemia Index (RHI) is a measure of endothelial function assessed using peripheral arterial tonometry (PAT) with the EndoPAT device (Itamar Medical Ltd., Caesarea, Israel). The type of the measure is continuous and no specified minimum or maximum value. RHI values \>1.67 are considered normal, whereas RHI values ≤1.67 are considered abnormal, with higher RHI values indicating better endothelial function.
| reactive hyperemia index | PAP Treatment | Sleep Education I |
|---|---|---|
| Reactive Hyperemia Index | 2.32 ± 0.75 | 1.84 ± 0.54 |
Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure will be calculated.
| mmHg | PAP Treatment | Sleep Education I |
|---|---|---|
| Mean 24-Hour Systolic Blood Pressure | 136.53 ± 14.41 | 120.6 ± 11.53 |
| Mean 24-Hour Diastolic Blood Pressure | 82.53 ± 8.49 | 72.50 ± 9.63 |
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a point scale of 1 to 7 from strongly disagree to strongly agree. The minimum possible score is 9 and highest score is 63. A higher score indicates more severe fatigue and impact on the person's activities.
| score on a scale | PAP Treatment | Sleep Education I |
|---|---|---|
| Fatigue Severity Scale (FSS) | 33.60 ± 12.61 | 32.40 ± 13.00 |
PVT is a performance measure of alertness and vigilance. Reaction time to a visual cue, delivered at random intervals varying from 2 to 10 seconds, is measured. The total number of lapses (reaction time \>500ms) during the 10 minute test will be used as a measure of objective alertness.
| number of lapses | PAP Treatment | Sleep Education I |
|---|---|---|
| Psychomotor Vigilance Test (PVT) | 2.29 ± 3.15 | 3.71 ± 7.06 |
Collected over 3 months after randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PAP Treatment | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Sleep Education I | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
Participants in PAP group received PAP treatment for 4 weeks. Participants in Sleep Education group received Sleep education for 4 weeks.
| Age, Categorical(Participants) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 54 | 107 |
| >=65 years | 14 | 8 | 22 |
| Age, Continuous(years) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| Mean | 52.7 ± 12.6 | 51.2 ± 11.6 | 52.0 ± 12.1 |
| Sex/Gender, Customized(Participants) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| Female | 38 | 36 | 74 |
| Male | 29 | 25 | 54 |
| Other | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 51 | 36 | 87 |
| White | 13 | 19 | 32 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 2 | 5 | 7 |
| Ethnicity (NIH/OMB)(Participants) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 62 | 57 | 119 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(participants) | PAP Treatment | Sleep Education I | Total |
|---|---|---|---|
| United States | 67 | 62 | 129 |
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