PAP + Motivational Enhancement for Obstructive Sleep Apnea

(Champion Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Naresh Punjabi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Insomnia, Commercial drivers, Unstable conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have unstable medical conditions or are using certain treatments for sleep apnea, you may not be eligible to participate.

What data supports the effectiveness of the treatment Motivational Enhancement Therapy (MET) for Obstructive Sleep Apnea?

Research shows that motivational interventions, like Motivational Enhancement Therapy (MET), can improve adherence to Positive Airway Pressure (PAP) therapy for Obstructive Sleep Apnea (OSA). Studies found that these interventions are more effective than usual care in helping patients stick to their CPAP treatment, although the benefits may not always last over time. ^{1 2 3 4 5}

Is PAP therapy with motivational enhancement safe for humans?

PAP therapy, including CPAP, BiPAP, and APAP, is generally considered safe for treating sleep apnea, and motivational enhancement techniques like Motivational Interviewing are used to improve adherence without known safety concerns. ^{1 2 5 6 7}

How is the PAP + Motivational Enhancement treatment different from other treatments for obstructive sleep apnea?

The PAP + Motivational Enhancement treatment is unique because it combines Positive Airway Pressure (PAP) therapy with Motivational Enhancement Therapy (MET) to improve adherence. This approach uses motivational strategies to encourage patients to stick with their PAP therapy, which is often a challenge with standard treatments. ^{2 3 4 5 7}

Research Team

Naresh Punjabi, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults over 18 with untreated moderate-to-severe obstructive sleep apnea who can attend study visits and have phone access. It's not for those with a history of OSA surgery, current PAP therapy users, commercial drivers, oxygen users during wakefulness or sleep, recent sleepy driving incidents, unstable medical conditions like uncontrolled heart issues or severe lung disease, active major psychiatric diseases, other sleep disorders, very low awake oxygen levels, insomnia sufferers or participants in another clinical trial.

Inclusion Criteria

I am 18 years old or older.

I have moderate-to-severe sleep apnea.

Reliable access to a phone

Exclusion Criteria

I have trouble sleeping, and it's either moderate or severe.

I do not have any severe health conditions like uncontrolled heart issues, severe lung disease, uncontrolled high blood pressure, or active major depression.

I have been diagnosed with a specific sleep disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Motivational Enhancement Therapy (MET) with PAP therapy or standard PAP therapy

12 weeks

Regular visits as per therapy protocol

Follow-up

Participants are monitored for adherence to PAP therapy and secondary outcomes like glucose levels and blood pressure

4 weeks

Treatment Details

Interventions

• Motivational Enhancement Therapy (Behavioral Intervention)
• Positive Airway Pressure (PAP) therapy (Procedure)

Trial Overview The study aims to see if motivational talks by community health workers help people stick to using their Positive Airway Pressure (PAP) machines compared to the usual care given to patients with obstructive sleep apnea. Participants will either receive this new approach or continue with standard treatment.

Participant Groups

Group I: Motivational Enhancement Therapy (MET) Experimental Treatment 2 Interventions

Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.

Group II: PAP therapy Active Control 1 Intervention

Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Dr. Eliseo J. Pérez-Stable

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Executive Officer since 2015

MD from University of Miami

Dr. Rada Dagher

National Institute on Minority Health and Health Disparities (NIMHD)

Chief Medical Officer since 2024

MD from University of California, San Francisco

Findings from Research

Both traditional education and motivational enhancement therapy (MET) were effective in reducing discontinuation of positive airway pressure (PAP) treatment for sleep apnea syndrome (SAS) compared to standard clinical care.

MET showed the best results when patients had flexible delivery options for PAP, suggesting that tailored approaches may improve adherence, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral therapies reduce early positive airway pressure discontinuation rates in sleep apnea syndrome: preliminary findings. Aloia, MS., Smith, K., Arnedt, JT., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Motivational Interviewing Effects on Positive Airway Pressure Therapy (PAP) Adherence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

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

Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Improving CPAP Adherence in Adults With Obstructive Sleep Apnea Syndrome: A Scoping Review of Motivational Interventions. [2023]

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

Motivational interviewing (MINT) improves continuous positive airway pressure (CPAP) acceptance and adherence: a randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Brief behavioral therapies reduce early positive airway pressure discontinuation rates in sleep apnea syndrome: preliminary findings. [2022]

6. England pubmed.ncbi.nlm.nih.gov

An Adaptive Treatment to Improve Positive Airway Pressure (PAP) Adherence in Patients With Obstructive Sleep Apnea: A Proof of Concept Trial. [2018]

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

Positive airway pressure: Making an impact on sleep apnea. [2020]