AIR: Apnea and Insomnia Relief Study

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04007796

Collaborator

(none)

Enrollment

Location

Arms

52.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes Insomnia Disorder Stress Disorders, Post-Traumatic	Behavioral: Apnea and Insomnia Relief (AIR) Behavioral: Sleep Education (SE)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

The clinical interviewer conducting outcome-related interviews will be masked.

Primary Purpose:

Treatment

Official Title:

Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

Actual Study Start Date :

Feb 27, 2020

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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)

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)

Outcome Measures

Primary Outcome Measures

World Health Organization Quality of Life (WHOQOL-BREF) [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.
World Health Organization Quality of Life (WHOQOL-BREF) [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 Outcome Measures

Functional Outcomes of Sleep Questionnaire (FOSQ-10) [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.
Functional Outcomes of Sleep Questionnaire (FOSQ-10) [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.
Insomnia Severity Index (ISI) [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.
Insomnia Severity Index (ISI) [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.
Total sleep time (actigraphy-based) [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.
CPAP Adherence [Past 7 days, at 1 week after treatment ends]
Average daily CPAP use.
CPAP Adherence [Past 7 days, at 3 months after treatment ends]
Average daily CPAP use.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study at San Francisco VA Healthcare System 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