RECRUITING

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.

Official Title

Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program

Quick Facts

Study Start:2023-01-02
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05156112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * a Veteran of the U.S. military or Reserve/National Guard member
  2. * at least 18 years of age
  3. * have an AHI 5 per hour
  4. * experienced trauma that occurred in childhood or adulthood; at least one month post-trauma
  5. * have current DSM-5 diagnoses of SUD via SCID-SUD module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)
  6. * Full PTSD diagnosis via clinician administered PTSD scale
  7. * are literate in English
  8. * are on the PTSD track of the SARRTP unit
  9. * are capable of giving informed consent
  1. * have central sleep apnea (AHI \>=5 and \> 50% central apneas)
  2. * arrives on the SARRTP unit already using a PAP device (Veteran's previously diagnosed with OSA, but not using PAP therapy will be eligible)
  3. * the SARRTP medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via MOCA \< 26)
  4. * history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress

Contacts and Locations

Study Contact

Peter Colvonen, PhD
CONTACT
(858) 552-8585
peter.colvonen@va.gov

Principal Investigator

Peter Colvonen, PhD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Peter Colvonen, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-02
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-01-02
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Veteran
  • PTSD
  • Obstructive Sleep Apnea
  • Substance Use Disorder
  • PAP Treatment
  • Residential Treatment

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder
  • Obstructive Sleep Apnea
  • Substance Use Disorder
  • Residential Treatment Program