Sleep ApneaNCT04868682
Addressing Insufficient PAP Use in Older Veterans
A study testing PAP Adherence Program in people with Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- PAP Adherence Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe obstructive sleep apnea (apnea hypopnea index [AHI] > or = 15)
- Previously prescribed positive airway pressure (PAP) therapy
- Insufficient PAP use (defined as no PAP use over the past 30 days)
Who cannot join
- Severe psychopathology (e.g., active psychosis) that precludes participation in the study
- Severe unstable medical illness that precludes participation in the study
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: Addressing Insufficient Positive Airway Pressure Use Among Older Veterans With Obstructive Sleep Apnea
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.
Read the detailed description
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.
- Conditions
- Sleep Apnea
- Being tested
- PAP Adherence Program, Active Control
- Keywords
- sleep apnea, positive airway pressure
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP Adherence ProgramBehavioural
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.
Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAP Adherence Program | Experimental | Manual-based behavioral treatment to improve PAP adherence and sleep. Receives: Behavioral: PAP Adherence Program |
| Active Control | Active comparator | Manual-based general sleep education program. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Nights 1 to 180 following randomization
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start10 Jan 2022
- Primary completion30 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cathy A. Alessi, MD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868682
- Sponsor's protocol ID
- IIR 20-046
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2021
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Insufficient Positive Airway Pressure Use Among Older Veterans With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04868682
- Acronym / sponsor ID
- IIR 20-046
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAP Adherence Program | Experimental | Behavioral: PAP Adherence ProgramManual-based behavioral treatment to improve PAP adherence and sleep. |
| Active Control | Active comparator | Behavioral: Active ControlManual-based general sleep education program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of moderate to severe obstructive sleep apnea (apnea hypopnea index [AHI] > or = 15)
- Previously prescribed positive airway pressure (PAP) therapy
- Insufficient PAP use (defined as no PAP use over the past 30 days)
Key exclusion criteria (3 listed)
- Severe psychopathology (e.g., active psychosis) that precludes participation in the study
- Severe unstable medical illness that precludes participation in the study
- Significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAP Adherence ProgramManual-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. | Behavioural | PAP Adherence Program |
| Active ControlManual-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. | Behavioural | Active Control |
Primary outcome
PAP Adherence
Time frame: Nights 1 to 180 following randomization
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.
3 secondary outcomes
Sleep Quality
Time frame: 6 months following randomization
Daytime Sleepiness
Time frame: 6 months following randomization
Sleep-related Function
Time frame: 6 months following randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy A. Alessi, MD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAP Adherence Program in people with Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAP Adherence (time frame: Nights 1 to 180 following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.