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Completed

NCT Number: NCT04007796

Apnea and Insomnia Relief Study

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. World Health Organization Quality of Life (WHOQOL-BREF)

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

    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.

  2. World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: Change from baseline to 3 months after treatment ends

    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.

Secondary outcomes

  1. Functional Outcomes of Sleep Questionnaire (FOSQ-10)

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

    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.

  2. Functional Outcomes of Sleep Questionnaire (FOSQ-10)

    Time frame: Change from baseline to 3 months after treatment ends

    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.

  3. Insomnia Severity Index (ISI)

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

    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.

  4. Insomnia Severity Index (ISI)

    Time frame: Change from baseline to 3 months after treatment ends

    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.

  5. Total Sleep Time (Actigraphy-based)

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

    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.

  6. CPAP Adherence

    Time frame: Past 7 days, at 1 week after treatment ends

    Average daily CPAP use.

  7. CPAP Adherence

    Time frame: Past 7 days, at 3 months after treatment ends

    Average daily CPAP use.

  8. Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

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

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

Acronym: AIR

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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