Apnea and Insomnia Relief Study

NCT04007796 | Completed Phase 2 Results

• 1 other identifier: D2952-W
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea Syndromes; Insomnia Disorder; Stress Disorders, Post-Traumatic

Keywords

Sleep Apnea Syndromes; Sleep Apnea, Central; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Insomnia; Insomnia Disorder; Stress Disorders, Post-Traumatic; PTSD; Veterans

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  Change from baseline to 1 week post-treatment (after 6 weeks)

• Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  Change from baseline to 3 months after treatment ends

• Insomnia Severity Index (ISI)

  Change from baseline to 1 week post-treatment (after 6 weeks)

• Insomnia Severity Index (ISI)

  Change from baseline to 3 months after treatment ends

• Total Sleep Time (Actigraphy-based)

  Change from baseline to 1 week post-treatment (after 6 weeks)

Study Arms (2)

Apnea and Insomnia Relief (AIR)

EXPERIMENTAL

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)

Sleep Education (SE)

ACTIVE COMPARATOR

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)

Interventions

Apnea and Insomnia Relief (AIR) BEHAVIORAL

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.

Apnea and Insomnia Relief (AIR)

Sleep Education (SE) BEHAVIORAL

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.

Sleep Education (SE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Sleep Apnea, Central; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Dr. Liz Goldstein
• Organization: San Francisco VA Health Care System

lizabeth.goldstein2@va.gov

415-694-3443

Study Officials

• Lizabeth A Goldstein, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical interviewer conducting outcome-related interviews will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: February 27, 2020
• Primary Completion: October 31, 2024
• Study Completion: February 17, 2025
• Last Updated: March 12, 2026
• Results First Posted: December 8, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)