CompletedPhase 2

Apnea and Insomnia Relief Study

United States36 participantsStarted 2020-02-27

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

World Health Organization Quality of Life (WHOQOL-BREF)

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)

World Health Organization Quality of Life (WHOQOL-BREF)

Timeframe: Change from baseline to 3 months after treatment ends

Trial details

NCT IDNCT04007796

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-10-31

Results submitted2025-10-22

View on ClinicalTrials.gov More Sleep Apnea Syndromes trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.