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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for sleep apnea with PTSD and substance use disorders?

Research shows that using CPAP (a machine that helps keep your airways open while you sleep) can improve PTSD symptoms and reduce nightmares in people with both PTSD and sleep apnea. Studies also suggest that advanced PAP therapies like ABPAP or ASV might help people stick with the treatment better by reducing discomfort. ^{1 2 3 4 5}

Is PAP treatment safe for people with PTSD and sleep apnea?

PAP treatments like CPAP are generally safe for humans, but people with PTSD and sleep apnea may experience discomfort with the pressure, which can be managed with advanced PAP modes like ABPAP or ASV. ^{1 2 5 6 7}

How is PAP treatment unique for sleep apnea in patients with PTSD and substance use disorders?

PAP treatment, including advanced modes like auto-bilevel PAP and adaptive servo-ventilation, is unique because it can reduce pressure intolerance and improve adherence in patients with both sleep apnea and PTSD, potentially decreasing PTSD severity and improving sleep quality. ^{1 2 3 6 7}

Research Team

Peter Colvonen, MD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Positive airway pressure adherence and subthreshold adherence in posttraumatic stress disorder patients with comorbid sleep apnea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving PTSD Symptoms and Preventing Progression of Subclinical PTSD to an Overt Disorder by Treating Comorbid OSA With CPAP. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Response to Cognitive Processing Therapy in Veterans With and Without Obstructive Sleep Apnea. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnosing obstructive sleep apnea in a residential treatment program for veterans with substance use disorder and PTSD. [2023]

5. United States 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Examining the bidirectional relationship between posttraumatic stress disorder symptom clusters and PAP adherence. [2023]

7. United States 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. [2018]