Apnea and Insomnia Relief Study

a study on Sleep Apnea Sleep Disorders Insomnia Post-Traumatic Stress Disorder Stress

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Lizabeth A Goldstein, PhD
Headshot of Lizabeth A Goldstein
Lizabeth A Goldstein

Description

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).

Official Title

Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder

Details

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.

Keywords

Sleep Apnea Syndromes, Insomnia Disorder, Stress Disorders, Post-Traumatic, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, PTSD, Veterans, Apnea, Disease, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, Apnea and Insomnia Relief (AIR), Sleep Education (SE)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • San Francisco VA Medical Center, San Francisco, CA accepting new patients
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Lizabeth A Goldstein, PhD
    As the recipient of a VA Rehabilitation R&D Career Development Award-2, I spend 75% effort advancing my research program and 25% effort providing clinical services to Veterans and CHAMPVA enrollees in the San Francisco VA Healthcare System.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04007796
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated
Contact us about this trial