AIR Sleep Treatment for PTSD-related Sleep Disorders
(AIR Trial)
LA
Overseen ByLizabeth A Goldstein, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial uses video calls to help veterans with PTSD, sleep apnea, and insomnia improve their sleep and daily functioning. The main goal is to enhance their quality of life by teaching better sleep habits. Veterans will also give feedback on how practical and acceptable they find the treatment.
Research Team
LA
Lizabeth A Goldstein, PhD
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA
Eligibility Criteria
This trial is for Veterans with both sleep apnea and insomnia, who also have PTSD or subthreshold PTSD. Participants must be diagnosed with sleep apnea (Apnea Hypopnea Index of at least 5) and recommended for PAP therapy. They should be willing to attend all sessions, read English well enough for treatment, and not have plans that interfere with regular attendance.Inclusion Criteria
Willing to attend all treatment and assessment appointments
You have been diagnosed with insomnia according to the DSM-5 guidelines.
I can read, understand, and communicate in English well enough for treatment and assessments.
See 2 more
Exclusion Criteria
I have recently changed or plan to change my medication for depression, anxiety, or sleep.
You do not have a stable place to live.
I have no travel or personal plans that would interfere with regular treatment.
See 7 more
Treatment Details
Interventions
- Apnea and Insomnia Relief (AIR) (Behavioral Intervention)
- Sleep Education (SE) (Behavioral Intervention)
Trial OverviewThe study is testing a behavioral sleep treatment called Apnea and Insomnia Relief (AIR), compared to Sleep Education (SE). The goal is to see if AIR can improve functioning and sleep quality in Veterans suffering from PTSD.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Apnea and Insomnia Relief (AIR)Experimental Treatment1 Intervention
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.
Group II: Sleep Education (SE)Active Control1 Intervention
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Trials
1,691
Recruited
3,759,000+