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Positive Airway Pressure Device
PAP Treatment for Sleep Apnea with PTSD and Substance Use Disorders
N/A
Recruiting
Led By Peter Colvonen, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of giving informed consent
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-sarrtp unit (28 days), 3-month follow up (90 days)
Awards & highlights
Study Summary
This trial is comparing the effects of treating obstructive sleep apnea in veterans with substance use disorder and posttraumatic stress disorder who are living in a residential setting. The investigators hypothesis is that treating OSA will have better functional, SUD, and PTSD outcomes.
Who is the study for?
This trial is for U.S. Veterans or Reserve/National Guard members who are at least 18 years old, have PTSD and SUD, can read English, and are in a residential treatment program. They must have experienced trauma and used substances for at least 20 days in the last three months. Those with severe cognitive issues, central sleep apnea, psychosis outside of substance use, or already using PAP devices cannot join.Check my eligibility
What is being tested?
The study tests if using a Positive Airway Pressure (PAP) device to treat Obstructive Sleep Apnea (OSA) improves overall function, PTSD symptoms, and substance use outcomes better than waiting for treatment among veterans with both SUD/PTSD in residential care.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of using PAP devices may include discomfort or irritation from the mask interface, dry nose or throat sensation due to airflow pressure changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study and can agree to participate.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-sarrtp unit (28 days), 3-month follow up (90 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-sarrtp unit (28 days), 3-month follow up (90 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Clinician Administered PTSD Scale (CAPS-5)
Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days
+1 moreSecondary outcome measures
PAP adherence rates
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PAP Treatment on SARRTP UnitExperimental Treatment1 Intervention
Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
Group II: Waitlist ControlActive Control1 Intervention
Veterans will not receive PAP device until after 3-month Follow Up.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,239 Total Patients Enrolled
Peter Colvonen, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
92 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a substance use disorder and have used substances for at least 20 days in the past 90 days.You have been diagnosed with PTSD using a specific scale administered by a clinician.You have a history of serious mental health issues like hallucinations or extreme excitement that were not caused by drugs or alcohol.You are currently receiving treatment for PTSD in the SARRTP unit.Criterion: You have an apnea-hypopnea index (AHI) of 5 or more per hour.I understand the study and can agree to participate.I have central sleep apnea with more than half of my breathing interruptions being central in nature.I am 18 years old or older.You have experienced a traumatic event at least one month ago, either as a child or as an adult.If you are already using a PAP device, you cannot participate in the study. However, if you have been diagnosed with OSA but are not using PAP therapy, you can still participate.You have a history of significant problems with thinking and memory.
Research Study Groups:
This trial has the following groups:- Group 1: PAP Treatment on SARRTP Unit
- Group 2: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical research actively recruiting participants?
"Data hosted on clinicaltrials.gov informs us that this medical trial is presently not accepting participants. It was originally posted on February 1st 2023 and last edited April 19th 2022. Despite being in its dormancy, there are still 1785 other clinical trials actively recruiting patients at the moment."
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