Apnea and Insomnia Relief Study (AIR)

VA Office of Research and Development

Status and phase: Enrolling; Phase 2

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

Treatments: Behavioral: Sleep Education (SE); Behavioral: Apnea and Insomnia Relief (AIR)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04007796

D2952-W

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Apnea and Insomnia Relief (AIR)

Experimental group

Description:

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.

Treatment:

Behavioral: Apnea and Insomnia Relief (AIR)

Sleep Education (SE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Education (SE)