Apnea and Insomnia Relief Study (AIR)

Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Stress Disorders, Post-Traumatic; Insomnia Disorder
• Intervention / Treatment: Behavioral: Apnea and Insomnia Relief (AIR); Behavioral: Sleep Education (SE)

Detailed Description

This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121-1563
      • San Francisco VA Medical Center, San Francisco, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apnea and Insomnia Relief (AIR); 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.	Behavioral: Apnea and Insomnia Relief (AIR); 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.
Active Comparator: Sleep Education (SE); 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.	Behavioral: Sleep Education (SE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life (WHOQOL-BREF)	This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.	Change from baseline to 1 week post-treatment (after 6 weeks)
World Health Organization Quality of Life (WHOQOL-BREF)	This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.	Change from baseline to 3 months after treatment ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes of Sleep Questionnaire (FOSQ-10)	This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.	Change from baseline to 1 week post-treatment (after 6 weeks)
Functional Outcomes of Sleep Questionnaire (FOSQ-10)	This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.	Change from baseline to 3 months after treatment ends
Insomnia Severity Index (ISI)	This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.	Change from baseline to 1 week post-treatment (after 6 weeks)
Insomnia Severity Index (ISI)	This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.	Change from baseline to 3 months after treatment ends
CPAP Adherence	Average daily CPAP use.	Past 7 days, at 1 week after treatment ends
CPAP Adherence	Average daily CPAP use.	Past 7 days, at 3 months after treatment ends
Total Sleep Time (Actigraphy-based)	An actigraph will be used to determine total sleep time. An actigraph is a validated objective sleep measurement device commonly used outside the laboratory setting to detect movement and infer sleep and wake based on wrist activity.	Change from baseline to 1 week post-treatment (after 6 weeks)
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	This 30-item semi-structured interview provides a dimensional and categorical measure of PTSD. The severity score is based on frequency and intensity of PTSD symptoms. Categorically, it determines presence of both lifetime and current PTSD. Current and lifetime PTSD will be assessed at pre-treatment. Only current PTSD will be assessed at post-treatment. This interview also assesses the onset and duration of symptoms, distress, impact of symptoms on functioning (social and occupational), change in symptoms since a previous administration, response validity, and dissociative subtype of PTSD. Total score ranging from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.	Change from baseline to 1 week post-treatment (after 6 weeks)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Lizabeth A Goldstein, PhD, San Francisco VA Medical Center, San Francisco, CA

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): February 17, 2025

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Veterans; Insomnia; Sleep Apnea, Obstructive; Stress Disorders, Post-Traumatic; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Insomnia Disorder; Sleep Apnea, Central
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Stress Disorders, Traumatic; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Sleep Apnea, Central
• Other Study ID Numbers: D2952-W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No