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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05156112
Recruitment Status : Recruiting
First Posted : December 14, 2021
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 30, 2021
First Posted Date  ICMJE December 14, 2021
Last Update Posted Date January 17, 2023
Actual Study Start Date  ICMJE January 2, 2023
Estimated Primary Completion Date May 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2021)
  • Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]
    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.
  • Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days [ Time Frame: Baseline, 3-Month Follow up (90 Days) ]
    Examining change in percentage of substance use in the past 90 days.
  • Change in Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]
    Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.
  • Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days) ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2021)
PAP adherence rates [ Time Frame: 3-Month Follow up (90 Days) ]
Examining average number of nights used positive airway pressure is use over the last 30 days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Official Title  ICMJE Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
Brief Summary 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.
Detailed Description

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having one condition worsens the course of the other. Individuals with both disorders exhibit worse functioning across a number of domains than individuals with either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Compared to Veterans with a single disorder, Veterans with SUD/PTSD also are more likely to have suicidal ideation and to have attempted suicide. Examining treatable conditions that are associated with improved SUD and PTSD outcomes, such as obstructive sleep apnea (OSA), can maximize treatment efficacy for Veterans at a critical time in recovery.

OSA is highly comorbid with both PTSD and SUD with upwards of 67 to 83% of Veterans with SUD or PTSD also having OSA. Further, untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, and higher substance use and relapse rates. Importantly, untreated OSA also contributes to higher suicide attempts and completion. Positive airway pressure (PAP) is the gold standard treatment for OSA with large effects on multiple domains of functioning, quality of life, PTSD symptoms, physical functioning, lower depression, and better emotional coping. Unfortunately, screening and treating Veterans for OSA is not a part of clinical practice for SUD or PTSD treatment; as such the average wait time for individuals to get PAP therapy is upward of two years. Despite the widespread dissemination of knowledge regarding the detrimental effects of untreated OSA and the incredible effectiveness of PAP treatment, OSA is rarely screened for or treated in patients with SUD or PTSD, with approximately 80% to 90% of Veterans with OSA remaining undiagnosed and untreated.

Methodology.

The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up. Participants will be 194 male and female Veterans on the residential SUD and PTSD unit with SUD, PTSD, and OSA. The primary aim is to determine the relative efficacy of PAP treatment on the SUD/PTSD unit, as compared to waitlist control, in reducing problematic substance use, PTSD symptoms, and suicidal ideation, while improving functioning among Veterans with comorbid SUD/PTSD at 3-months post-treatment follow-up. The investigators will also compare PAP adherence rates on PTSD/SUD/functioning outcomes within the PAP treatment group (3-months). Finally, the investigators plan on comparing adherence rates between the two treatment groups at the 6-months post-treatment follow-up assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up.
Masking: Single (Outcomes Assessor)
Masking Description:
All assessors will be blinded to treatment condition to minimize bias in outcome assessments
Primary Purpose: Treatment
Condition  ICMJE
  • Post Traumatic Stress Disorder
  • Obstructive Sleep Apnea
  • Substance Use Disorder
  • Residential Treatment Program
Intervention  ICMJE Device: Positive Airway Pressure Device
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).
Other Name: PAP; CPAP; Auto-PAP
Study Arms  ICMJE
  • Experimental: PAP Treatment on SARRTP Unit
    Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
    Intervention: Device: Positive Airway Pressure Device
  • No Intervention: Waitlist Control
    Veterans will not receive PAP device until after 3-month Follow Up.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2021)
194
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2027
Estimated Primary Completion Date May 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Colvonen, PhD (858) 552-8585 ext 2468 peter.colvonen@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05156112
Other Study ID Numbers  ICMJE D3623-R
1I01RX003623-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party VA Office of Research and Development
Original Responsible Party Same as current
Current Study Sponsor  ICMJE VA Office of Research and Development
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Colvonen, PhD VA San Diego Healthcare System, San Diego, CA
PRS Account VA Office of Research and Development
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP