OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
Sponsor study identifier
Secondary identifiers
interventional
194
1 country
1
Study Start
January 2, 2023
Actual (reported)Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2021
Actual (reported)December 14, 2021
Actual (reported)January 2, 2023
Actual (reported)May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in functional impairment across multiple domains. The WHODAS 2.0 is a 36-item questionnaire that assess functional impairment across 5 subscales: cognitions (understanding and communicating), mobility, self-care getting along with others, household responsibilities, work responsibilities, and community participation.
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days
Examining change in percentage of substance use in the past 90 days.
Baseline, 3-Month Follow up (90 Days)
Change in Clinician Administered PTSD Scale (CAPS-5)
Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.
Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
Veterans will not receive PAP device until after 3-month Follow Up.
Each PAP treatment initiation meeting will include 1) mask fitting; 2) psycho-education to what to expect and reviewing PAP machine problem solving; and 3) setting up correct PAP treatment (e.g., auto PAP or in rare conditions, bi-level PAP).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
Peter Colvonen, PhD
VA San Diego Healthcare System, San Diego, CA
First Submitted
November 30, 2021
First Posted
December 14, 2021
Study Start
January 2, 2023
Adaptation of Written Exposure Therapy in Substance Treatment
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in suicidal ideation severity using the C-SSRS. The C-SSRS is a standardized 8-point clinician-administered suicidal rating system designed to track suicidal adverse events across a treatment trial and covering the wide spectrum of suicidality
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Positive airway pressure (PAP) adherence rates
3-Month Follow up (90 Days)
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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