← Back to Search

AIR Sleep Treatment for PTSD-related Sleep Disorders (AIR Trial)

Phase 2
Recruiting
Led By Lizabeth A Goldstein, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
Must not have
Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past 7 days, at 3 months after treatment ends
Awards & highlights

Summary

This trial will test whether a sleep treatment can help improve sleep and functioning in Veterans with PTSD.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions are behavioral treatments rather than medications, there may not be traditional side effects. However, participants might experience discomfort or changes in their sleeping patterns as they adjust to new behaviors taught during the treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD or have symptoms of PTSD.
Select...
I am a veteran diagnosed with sleep apnea and advised to use a PAP machine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe thoughts of harming myself or others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past 7 days, at 3 months after treatment ends
This trial's timeline: 3 weeks for screening, Varies for treatment, and past 7 days, at 3 months after treatment ends for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
World Health Organization Quality of Life (WHOQOL-BREF)
Secondary outcome measures
CPAP Adherence
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
+2 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and sleep hygiene education, work by addressing the maladaptive thoughts and behaviors that contribute to poor sleep. CBT-I uses techniques like stimulus control, sleep restriction, and cognitive restructuring to improve sleep patterns. Sleep hygiene education focuses on establishing regular sleep-wake schedules, reducing screen time before bed, and creating a conducive sleep environment. These interventions are crucial for PTSD patients as they help break the cycle of anxiety and poor sleep, thereby reducing PTSD symptoms and improving overall quality of life.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,899 Total Patients Enrolled
Lizabeth A Goldstein, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA

Media Library

Apnea and Insomnia Relief (AIR) Clinical Trial Eligibility Overview. Trial Name: NCT04007796 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Sleep Education (SE), Apnea and Insomnia Relief (AIR)
Post-Traumatic Stress Disorder Clinical Trial 2023: Apnea and Insomnia Relief (AIR) Highlights & Side Effects. Trial Name: NCT04007796 — Phase 2
Apnea and Insomnia Relief (AIR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007796 — Phase 2
~0 spots leftby Jul 2024