Clinical trial NCT04007796: Apnea and Insomnia Relief Study
Official title: Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-07-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Change from baseline to 1 week post-treatment (after 6 weeks)
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Change from baseline to 3 months after treatment ends
Secondary outcomes:
measure: Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: Change from baseline to 1 week post-treatment (after 6 weeks)
measure: Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: Change from baseline to 3 months after treatment ends
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 1 week post-treatment (after 6 weeks)
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 3 months after treatment ends
measure: Total sleep time (actigraphy-based)
timeFrame: Change from baseline to 1 week post-treatment (after 6 weeks)
measure: CPAP Adherence
timeFrame: Past 7 days, at 1 week after treatment ends
measure: CPAP Adherence
timeFrame: Past 7 days, at 3 months after treatment ends
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change from baseline to 1 week post-treatment (after 6 weeks)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Lizabeth A Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: