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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
English literacy and cognition sufficient to participate in treatment and assessment
Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past 7 days, at 3 months after treatment ends
Awards & highlights

AIR Trial 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.

AIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read, understand, and communicate in English well enough for treatment and assessments.
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I have been diagnosed with PTSD or have symptoms of PTSD.
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I am a veteran diagnosed with sleep apnea and advised to use a PAP machine.

AIR Trial 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

AIR 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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,955 Total Patients Enrolled
27 Trials studying Insomnia
4,197 Patients Enrolled for Insomnia
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
Insomnia Research Study Groups: Apnea and Insomnia Relief (AIR), Sleep Education (SE)
Insomnia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential perils might arise from using Apnea and Insomnia Relief (AIR)?

"The safety of Apnea and Insomnia Relief (AIR) was evaluated to be a 2 on the scale, as this is only in Phase 2. This implies there is evidence that it's safe, but not yet any proof of its efficacy."

Answered by AI

Is enrolment for this trial still ongoing?

"According to clinicaltrials.gov, this research trial is currently accepting patient candidates. The proposal was originally listed on February 27th 2020 and the last update occurred on January 12th 2022."

Answered by AI

How many participants have been enrolled in this trial thus far?

"Affirmative, according to clinicaltrials.gov the trial was initially announced on February 27th 2020 and is currently recruiting participants with a goal of 80 patients across only 1 medical centre."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Francisco VA Medical Center, San Francisco, CA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~0 spots leftby Mar 2024