PAP Treatment for Sleep Apnea with PTSD and Substance Use Disorders

Overseen By Peter Colvonen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Central sleep apnea, Severe cognitive impairment, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if treating sleep apnea with a Positive Airway Pressure (PAP) device can improve the lives of Veterans dealing with both PTSD and substance use disorders. Researchers seek to compare outcomes between using the PAP device during a residential treatment program and delaying sleep apnea treatment. Veterans who have experienced trauma, have been diagnosed with both PTSD and a substance use disorder, and are not currently using a PAP device may be suitable candidates for this trial. As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could enhance treatment strategies for complex conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Positive Airway Pressure device is safe for treating sleep apnea in Veterans with SUD/PTSD?

Research shows that using a Positive Airway Pressure (PAP) device is generally easy to adapt to and helps with sleep problems. Studies have found that PAP can significantly reduce the severity of obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. It also helps reduce daytime tiredness and lowers blood pressure.

Evidence indicates that PAP can improve symptoms in people with posttraumatic stress disorder (PTSD) and enhance overall sleep quality. While PAP is generally safe, some users might experience minor side effects like a stuffy nose or discomfort from the mask. However, these issues are usually manageable and often lessen over time with regular use.

Overall, PAP treatment is considered safe for many people, including those with PTSD and substance use disorders (SUD). Following guidelines and consulting healthcare professionals is important to ensure the best experience with the device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Positive Airway Pressure (PAP) devices for treating sleep apnea in veterans with PTSD and substance use disorders because it combines respiratory therapy with mental health support. Unlike standard treatments that may separately address sleep apnea or PTSD, this approach targets both issues at once. By providing consistent airway pressure, the PAP device can improve sleep quality, which may also help alleviate PTSD symptoms and reduce substance dependency. This holistic approach could lead to better overall outcomes for veterans, making it a promising area of study.

What evidence suggests that this positive airway pressure device is effective for sleep apnea?

Research shows that a Positive Airway Pressure (PAP) device can effectively treat obstructive sleep apnea (OSA), often linked to PTSD and substance use disorder (SUD). Studies have found that PAP therapy can reduce PTSD symptoms and improve sleep quality and duration for those with OSA. One study discovered that treating OSA with PAP reliably reduced PTSD severity and lessened nightmares. However, adhering to PAP treatment can be challenging, especially for those with PTSD. In this trial, some participants will receive PAP treatment while on the SARRTP Unit, while others will be in a waitlist control group and will not receive the PAP device until after a 3-month follow-up. Overall, PAP therapy offers a promising way to improve outcomes for people with both PTSD and OSA. ^{2 3 6 7 8}

Who Is on the Research Team?

Peter Colvonen, MD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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.

Inclusion 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 are currently receiving treatment for PTSD in the SARRTP unit.

Exclusion Criteria

You have a history of serious mental health issues like hallucinations or extreme excitement that were not caused by drugs or alcohol.

I have central sleep apnea with more than half of my breathing interruptions being central in nature.

SARRTP medical staff advises against the study based on medical history and physical examination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Positive Airway Pressure (PAP) treatment while on the 28-day SARRTP Unit

4 weeks

Continuous residential stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PAP adherence and functional outcomes

3 months

1 visit (in-person) at 3-month follow-up

Extended Follow-up

Comparison of adherence rates between treatment groups at 6-months post-treatment follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Positive Airway Pressure Device

Trial Overview 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.

How Is the Trial Designed?

Group I: PAP Treatment on SARRTP Unit Experimental Treatment 1 Intervention

Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.

Group II: Waitlist Control Active Control 1 Intervention

Veterans will not receive PAP device until after 3-month Follow Up.

Positive Airway Pressure Device is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in European Union as Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Canada as Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Japan as Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Veterans with obstructive sleep apnea (OSA) experienced greater PTSD severity during and after cognitive processing therapy (CPT) compared to those without OSA, indicating that sleep disturbances may hinder treatment effectiveness.

Access to continuous positive airway pressure (CPAP) therapy significantly reduced PTSD severity in OSA-positive veterans, suggesting that improving sleep quality could enhance the outcomes of trauma-focused psychotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to Cognitive Processing Therapy in Veterans With and Without Obstructive Sleep Apnea. Mesa, F., Dickstein, BD., Wooten, VD., et al.[2018]

In a study involving 42 veterans with PTSD and obstructive sleep apnea, CPAP therapy was found to be more effective than a mandibular advancement device (MAD) in reducing apnea-hypopnea index (AHI) and improving nocturnal oxygenation.

Despite CPAP's superior efficacy for sleep apnea, adherence to MAD was significantly higher, with 58% of participants preferring MAD, suggesting it may be a better option for veterans who struggle with CPAP compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder. El-Solh, AA., Homish, GG., Ditursi, G., et al.[2018]

Objective sleep apnea (OSA) diagnostic testing was successfully completed by 95.7% of the 47 veterans in a residential treatment program for PTSD and substance use disorders, indicating high feasibility and acceptability of the testing procedures.

The study found that 35.6% of participants received a new diagnosis of OSA, highlighting the importance of routine OSA screening in this population, as many cases may go undiagnosed and untreated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosing obstructive sleep apnea in a residential treatment program for veterans with substance use disorder and PTSD. Colvonen, PJ., Rivera, GL., Straus, LD., et al.[2023]

In a study of 147 patients with PTSD and obstructive sleep apnea who previously rejected CPAP, the use of advanced PAP therapy modes (ABPAP or ASV) led to a higher adherence rate of 58%, which is significantly better than previously reported rates for this population.

The findings suggest that advanced PAP modes can effectively reduce expiratory pressure intolerance and improve patient compliance, indicating a need for further research on these therapies in managing CPAP failure among PTSD patients with OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive airway pressure adherence and subthreshold adherence in posttraumatic stress disorder patients with comorbid sleep apnea. Krakow, BJ., Obando, JJ., Ulibarri, VA., et al.[2022]

In a study of 41 veterans with PTSD and obstructive sleep apnea, higher levels of re-experiencing and hyperarousal symptoms were linked to lower adherence to positive airway pressure (PAP) therapy, highlighting the challenge of treatment compliance in this population.

Veterans who adhered more to PAP therapy experienced a significant reduction in PTSD symptoms, with high adherent individuals showing a 14.36-point decrease in PTSD severity compared to just 3.66 points in low adherent individuals, suggesting that improving PAP adherence could lead to better PTSD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the bidirectional relationship between posttraumatic stress disorder symptom clusters and PAP adherence. Colvonen, PJ., Goldstein, LA., Sarmiento, KF.[2023]

Continuous positive airway pressure (CPAP) treatment significantly reduces nightmares and overall PTSD symptoms in patients with both PTSD and obstructive sleep apnea, based on a meta-analysis of six studies.

Improvements in PTSD symptoms were linked to how well patients adhered to CPAP treatment, highlighting the importance of consistent use for effective symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of treating obstructive sleep apnea with continuous positive airway pressure on posttraumatic stress disorder: A systematic review and meta-analysis with hypothetical model. Zhang, Y., Ren, R., Yang, L., et al.[2020]

In a study of 192 veterans with obstructive sleep apnea (OSA), CPAP therapy significantly reduced PTSD symptoms and nightmare frequency in those with PTSD, even at lower compliance levels, indicating its efficacy in this population.

Conversely, non-PTSD veterans showed an increase in PTSD symptoms with low CPAP compliance, suggesting that untreated OSA may exacerbate mental health issues, highlighting the importance of adherence to CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving PTSD Symptoms and Preventing Progression of Subclinical PTSD to an Overt Disorder by Treating Comorbid OSA With CPAP. Ullah, MI., Campbell, DG., Bhagat, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11760215/

Development of a guide for continuous positive airway ... Our guide will serve as an effective self-help tool to improve CPAP adherence. It may result in the improvement of various medical and psychiatric conditions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5656482/

A Randomized Crossover Trial Evaluating Continuous ... OSA syndrome and posttraumatic stress disorder: clinical outcomes and impact of positive airway pressure therapy. Chest. 2016;149(2):483–490. doi: 10.1378 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02019914

Effects of CPAP Therapy on PTSD Symptoms The study hypotheses are that CPAP use will improve PTSD symptoms overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945717300345

The effect of continuous positive airway pressure on post- ... The findings indicated that treatment of OSA reduced PTSD severity and diminished frequency of nightmares to a degree that was both reliable and statistically ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.2260

The Impact of Posttraumatic Stress Disorder on CPAP ... While CPAP is an effective therapy for obstructive sleep apnea, compliance is often worsened in patients with PTSD. Study Impact: In a cohort of young combat ...

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A Narrative Review of the Association between Post- ... Recent decades have shown a strong, bidirectional relationship between PTSD and sleep problems, with OSA being an increasingly recognized contributor.

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7638

Treatment of Adult Obstructive Sleep Apnea With Positive ... The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...

8. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05156112

OSA PAP Treatment for Veterans With SUD and PTSD on ... Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across ...