Apnea and Insomnia Relief Study (NCT04007796) | Clinical Trial Compass
CompletedPhase 2
Apnea and Insomnia Relief Study
United States36 participantsStarted 2020-02-27
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
World Health Organization Quality of Life (WHOQOL-BREF)
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)
2
World Health Organization Quality of Life (WHOQOL-BREF)
Timeframe: Change from baseline to 3 months after treatment ends