PAP treatment for veterans with PTSD and substance use disorder
Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
This study tests if using a breathing device for sleep apnea can help veterans with PTSD and substance use issues stick to their treatment and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05156112 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) in veterans who are undergoing residential treatment for post-traumatic stress disorder (PTSD) and substance use disorder (SUD). It compares the outcomes of veterans receiving PAP therapy to those on a waitlist control group. The study aims to determine if treating OSA can improve overall treatment adherence and outcomes for veterans struggling with these co-occurring conditions. Given the high comorbidity of OSA with PTSD and SUD, this approach seeks to enhance recovery during a critical time in the veterans' treatment journey.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 and older with a diagnosis of PTSD and substance use disorder who also have obstructive sleep apnea.
Not a fit: Patients with central sleep apnea or those already using a PAP device prior to the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and recovery outcomes for veterans suffering from PTSD and substance use disorder.
How similar studies have performed: Other studies have shown promising results in treating OSA in populations with PTSD and SUD, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a Veteran of the U.S. military or Reserve/National Guard member * at least 18 years of age * have an AHI 5 per hour * experienced trauma that occurred in childhood or adulthood; at least one month post-trauma * 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) * Full PTSD diagnosis via clinician administered PTSD scale * are literate in English * are on the PTSD track of the SARRTP unit * are capable of giving informed consent Exclusion Criteria: * have central sleep apnea (AHI \>=5 and \> 50% central apneas) * arrives on the SARRTP unit already using a PAP device (Veteran's previously diagnosed with OSA, but not using PAP therapy will be eligible) * the SARRTP medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via MOCA \< 26) * history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress
Where this trial is running
San Diego, California
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Peter Colvonen, PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Peter Colvonen, PhD
- Email: peter.colvonen@va.gov
- Phone: (858) 552-8585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.