An interventional study of PAP Adherence Program and Active Control in Sleep Apnea, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Obstructive sleep apnea (OSA) is a common problem among middle-aged and older Veterans that is associated with poor nighttime sleep, more daytime sleepiness, poor functioning and worse quality of life. The recommended therapy for most patients with OSA is positive airway pressure (PAP) therapy; however, over time many patients prescribed PAP therapy no longer use it regularly. This study will test the effects of an behavioral treatment specifically designed for middle-aged and older Veterans who have stopped using their PAP device, or are not using it regularly.
Eligible Veterans who are enrolled into the study will receive a baseline assessment that includes questionnaires about sleep, health, and quality of life. After completing the baseline assessment, participants will be randomly assigned to one of two groups. Both groups will meet individually with a "sleep coach" for 5 session over 8 weeks, then they will be contacted by the sleep coach monthly by telephone for up to 6 months. Participants will complete follow-up assessments immediately after the fifth education session and again at 6-months and 12-months.
If successful, this approach has the potential to improve sleep, function and quality of life in middle-aged and older Veterans with OSA.
Background: The most frequently diagnosed sleep disorder among middle-aged and older Veterans is obstructive sleep apnea (OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway pressure (PAP) is recommended as first-line treatment (particularly for moderate to severe OSA), but sustained use is difficult to achieve, including among middle-aged and older Veterans, and nearly half of patients with OSA who begin PAP therapy discontinue use within a year.
Significance/Impact: Although OSA is a chronic condition, research to date has primarily focused on increasing initial PAP use in patients with newly diagnosed OSA. In addition, most research has not addressed PAP use in older adults, which is unfortunate given the high prevalence and important adverse effects of OSA on their health and well-being. Prior work suggests that behavioral interventions are effective in improving initial PAP use, but little is known of how to address insufficient PAP use over time.
Innovation: To address this problem, the investigators developed and pilot-tested a structured, manual-based behavioral treatment to address insufficient PAP use among middle-aged and older adults with previously diagnosed OSA. The intervention (5 individual virtual sessions over 8 weeks, then monthly brief telephone contact for up to 6 months) is designed so it can be provided by individuals ("sleep coaches") from various disciplines (supervised remotely by a psychologist) in a variety of settings for maximal implementation.
Specific Aims: Primary Aim 1 will test the efficacy of this intervention for improving PAP usage among middle-aged and older Veterans with previously diagnosed moderate or severe OSA who have insufficient PAP use. The hypotheses are that the intervention will increase objectively measured PAP use over 6-months follow-up, with effects sustained over 12 months. Secondary Aim 2 will test for effects on sleep quality, daytime sleepiness and sleep-related function; and Exploratory Aim 3 will test for effects on health-related quality of life. The hypotheses are that these outcomes will also improve at 6 months, and effects will be sustained at 12 months.
Methodology: The investigators are conducting a randomized, controlled trial to test this new intervention in middle-aged and older Veterans (N=106) with previously diagnosed OSA (moderate or severe) who were prescribed PAP, but have insufficient PAP use (defined as no PAP use over the prior 30 days). Participants will be randomized to one of two groups. Structured assessments at baseline, post-treatment (after session 5) and 6- and 12-months follow-up include objectively measured PAP use (via remote telemonitoring), sleep quality, daytime sleepiness, sleep-related function and health-related quality of life. The investigators will also collect participant experiences and attitudes related to the intervention, and implementation outcome measures (e.g., acceptability, appropriateness, fidelity and staff time as an estimate of cost) to inform future implementation.
Implementation/Next Steps: The long-term goal of this work is to effectively address insufficient PAP use among middle-aged and older Veterans with OSA to improve their sleep and quality of life. If successful, the investigators will develop an implementation package to promote wider implementation of this model of care into clinical practice.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's enrollment of 106 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Manual-based behavioral treatment to improve PAP adherence and sleep.
Behavioral: PAP Adherence Program
Manual-based general sleep education program.
Behavioral: Active Control
Manual-based treatment focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep. The intervention involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a behavioral sleep medicine psychologist.
Manual-based general sleep education program. The active control involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a study clinician.
PAP Adherence
Mean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.
Time frame: Nights 1 to 180 following randomization
Sleep Quality
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Time frame: 6 months following randomization
Daytime Sleepiness
Total score on the Epworth Sleepiness Scale will be used as a measure of daytime sleepiness. Score range from 0-24. Higher scores indicate worse outcome.
Time frame: 6 months following randomization
Sleep-related Function
Total score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be used as a measure of sleep-related function. Scores range from 5-20. Lower scores indicate worse outcome.
Time frame: 6 months following randomization
| Milestone | PAP Adherence Program | Active Control |
|---|---|---|
| Started | 53 | 53 |
| Completed | 51 | 50 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: 1 refused assessment; 1 in residing in a nursing home; 1 assessment was missed by staff | 1 | 2 |
| Milestone | PAP Adherence Program | Active Control |
|---|---|---|
| Started | 53 | 53 |
| Completed | 51 | 52 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Refused | 0 | 1 |
| Milestone | PAP Adherence Program | Active Control |
|---|---|---|
| Started | 52 | 53 |
| Completed | 50 | 51 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Death | 0 | 1 |
Mean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.
| hours per night | PAP Adherence Program | Active Control |
|---|---|---|
| PAP Adherence | 2.16 ± 0.26 | 0.87 ± 0.19 |
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
| score on a scale | PAP Adherence Program | Active Control |
|---|---|---|
| Sleep Quality | 7.72 ± 0.60 | 8.01 ± 0.59 |
Total score on the Epworth Sleepiness Scale will be used as a measure of daytime sleepiness. Score range from 0-24. Higher scores indicate worse outcome.
| score on a scale | PAP Adherence Program | Active Control |
|---|---|---|
| Daytime Sleepiness | 6.11 ± 0.67 | 7.59 ± 0.67 |
Total score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be used as a measure of sleep-related function. Scores range from 5-20. Lower scores indicate worse outcome.
| score on a scale | PAP Adherence Program | Active Control |
|---|---|---|
| Sleep-related Function | 14.65 ± 0.50 | 15.67 ± 0.50 |
Collected over One year following randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PAP Adherence Program | 1/53 (1.9%) | 6/53 (11.3%) | 0/53 (0%) |
| Active Control | 1/53 (1.9%) | 1/53 (1.9%) | 0/53 (0%) |
| Event | PAP Adherence Program | Active Control |
|---|---|---|
| HospitalizationInfections and infestations | 3/53 | 0/53 |
| HospitalizationCardiac disorders | 2/53 | 1/53 |
| Mental health distressPsychiatric disorders | 1/53 | 0/53 |
| HospitalizationGeneral disorders | 1/53 | 0/53 |
| HospitalizationRenal and urinary disorders | 1/53 | 0/53 |
| Age, Continuous(years) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Mean | 67.1 ± 9.7 | 65.5 ± 9.1 | 66.3 ± 9.4 |
| Sex: Female, Male(Participants) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 46 | 48 | 94 |
| Ethnicity (NIH/OMB)(Participants) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 16 | 25 |
| Not Hispanic or Latino | 44 | 37 | 81 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 21 | 17 | 38 |
| White | 22 | 25 | 47 |
| More than one race | 4 | 4 | 8 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Pittsburgh Sleep Quality Index(units on a scale) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Mean | 10.4 ± 4.5 | 9.9 ± 4.1 | 10.2 ± 4.3 |
| Epworth Sleepiness Scale(units on a scale) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Mean | 9.5 ± 5.4 | 8.3 ± 4.9 | 8.9 ± 5.2 |
| Functional Outcomes of Sleep Questionnaire-10 items(units on a scale) | PAP Adherence Program | Active Control | Total |
|---|---|---|---|
| Mean | 14.0 ± 3.5 | 14.9 ± 3.7 | 14.4 ± 3.6 |
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