AIR Sleep Treatment for PTSD-related Sleep Disorders

(AIR Trial)

Overseen By Lizabeth A Goldstein, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Must not be taking: Antidepressants, Anxiolytics, Sleep medications

Disqualifiers: Psychosis, Substance use disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

34 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Lizabeth A Goldstein, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral sleep treatment via telehealth over six sessions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in quality of life, sleep-related functioning, and PTSD symptom severity

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Apnea and Insomnia Relief (AIR)
• Sleep Education (SE)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Apnea and Insomnia Relief (AIR) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+