Sleep Apnea SyndromesPhase 2AIRNCT04007796
Apnea and Insomnia Relief Study
A Phase 2 study testing Apnea and Insomnia Relief (AIR) and Sleep Education (SE) in people with Sleep Apnea Syndromes and Insomnia Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Insomnia Disorder, Stress Disorders, Post-Traumatic
- What is being tested?
- Apnea and Insomnia Relief (AIR) and Sleep Education (SE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 17 Feb 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
- Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
- Meet DSM-5 Criteria for Insomnia Disorder
- Willing to attend all treatment and assessment appointments
- English literacy and cognition sufficient to participate in treatment and assessment
Who cannot join
- Psychosis or manic episode in last 5 years
- Moderate or severe substance use disorder in past 6 months
- Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
- Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
- Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
- Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator)
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- Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator)
- Working night shifts or rotating shifts that include night shifts
- Lack of stable housing
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
Official title: Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Read the detailed description
This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.
- Being tested
- Apnea and Insomnia Relief (AIR), Sleep Education (SE)
- Keywords
- Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Stress Disorders, Post-Traumatic, PTSD, Veterans
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic, Sleep Apnea, Central, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnea and Insomnia Relief (AIR)Behavioural
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Sleep Education (SE)Behavioural
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia. Receives: Behavioral: Apnea and Insomnia Relief (AIR) |
| Sleep Education (SE) | Active comparator | This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. Receives: Behavioral: Sleep Education (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life (WHOQOL-BREF)
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks)
World Health Organization Quality of Life (WHOQOL-BREF)
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Measured: Change from baseline to 3 months after treatment ends
Secondary outcomes (8)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.
Measured: Change from baseline to 3 months after treatment ends
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks)
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Measured: Change from baseline to 3 months after treatment ends
Total Sleep Time (Actigraphy-based)
An actigraph will be used to determine total sleep time. An actigraph is a validated objective sleep measurement device commonly used outside the laboratory setting to detect movement and infer sleep and wake based on wrist activity.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks)
CPAP Adherence
Average daily CPAP use.
Measured: Past 7 days, at 1 week after treatment ends
CPAP Adherence
Average daily CPAP use.
Measured: Past 7 days, at 3 months after treatment ends
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
This 30-item semi-structured interview provides a dimensional and categorical measure of PTSD. The severity score is based on frequency and intensity of PTSD symptoms. Categorically, it determines presence of both lifetime and current PTSD. Current and lifetime PTSD will be assessed at pre-treatment. Only current PTSD will be assessed at post-treatment. This interview also assesses the onset and duration of symptoms, distress, impact of symptoms on functioning (social and occupational), change in symptoms since a previous administration, response validity, and dissociative subtype of PTSD. Total score ranging from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start27 Feb 2020
- Primary completion31 Oct 2024
- Study completion17 Feb 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 Apnea SyndromesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lizabeth A Goldstein, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007796
- Sponsor's protocol ID
- D2952-W
- Acronym
- AIR
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2019
- Last updated
- 12 Mar 2026
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04007796
- Acronym / sponsor ID
- AIR / D2952-W
- Keywords
- Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Stress Disorders, Post-Traumatic, PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Detailed description
This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | Behavioral: Apnea and Insomnia Relief (AIR)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia. |
| Sleep Education (SE) | Active comparator | Behavioral: Sleep Education (SE)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
- Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
- Meet DSM-5 Criteria for Insomnia Disorder
- Willing to attend all treatment and assessment appointments
- English literacy and cognition sufficient to participate in treatment and assessment
Key exclusion criteria (10 listed)
- Psychosis or manic episode in last 5 years
- Moderate or severe substance use disorder in past 6 months
- Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
- Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
- Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
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 |
|---|---|---|
| Apnea and Insomnia Relief (AIR)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia. | Behavioural | Apnea and Insomnia Relief (AIR) |
| Sleep Education (SE)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. | Behavioural | Sleep Education (SE) |
Primary outcome
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Change from baseline to 3 months after treatment ends
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
8 secondary outcomes
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Change from baseline to 3 months after treatment ends
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 3 months after treatment ends
Total Sleep Time (Actigraphy-based)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
CPAP Adherence
Time frame: Past 7 days, at 1 week after treatment ends
CPAP Adherence
Time frame: Past 7 days, at 3 months after treatment ends
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lizabeth A Goldstein, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apnea and Insomnia Relief (AIR) and Sleep Education (SE) in people with Sleep Apnea Syndromes and Insomnia Disorder, 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 5 inclusion and 10 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 12 Mar 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 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?
World Health Organization Quality of Life (WHOQOL-BREF) (time frame: Change from baseline to 1 week post-treatment (after 6 weeks)). The study lists 2 primary outcomes in all. 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 12 Mar 2026.