Apnea and Insomnia Relief Study

Stress Disorders, Post-Traumatic Clinical Trial

— AIR  

Official title:

Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04007796
• Other study ID #: D2952-W
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Lizabeth A Goldstein, PhD
• Phone: (415) 221-4810
• Email: Lizabeth.Goldstein2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Insomnia Disorder
• Sleep Apnea Syndromes
• Sleep Initiation and Maintenance Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	World Health Organization Quality of Life (WHOQOL-BREF)	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.	Change from baseline to 1 week post-treatment (after 6 weeks)
Primary	World Health Organization Quality of Life (WHOQOL-BREF)	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.	Change from baseline to 3 months after treatment ends
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ-10)	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.	Change from baseline to 1 week post-treatment (after 6 weeks)
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ-10)	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.	Change from baseline to 3 months after treatment ends
Secondary	Insomnia Severity Index (ISI)	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.	Change from baseline to 1 week post-treatment (after 6 weeks)
Secondary	Insomnia Severity Index (ISI)	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.	Change from baseline to 3 months after treatment ends
Secondary	Total sleep time (actigraphy-based)	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.	Change from baseline to 1 week post-treatment (after 6 weeks)
Secondary	CPAP Adherence	Average daily CPAP use.	Past 7 days, at 1 week after treatment ends
Secondary	CPAP Adherence	Average daily CPAP use.	Past 7 days, at 3 months after treatment ends
Secondary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	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.	Change from baseline to 1 week post-treatment (after 6 weeks)