PAP + Motivational Enhancement for Obstructive Sleep Apnea

(Champion Trial)

Overseen By Naresh Punjabi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Insomnia, Commercial drivers, Unstable conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

98 Participants Needed

Trial Summary

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}

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.

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 have moderate-to-severe sleep apnea.

Reliable access to a phone

Available to attend study visits and sessions

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.

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
• Positive Airway Pressure (PAP) therapy

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.

Motivational Enhancement Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Motivational Enhancement Therapy for:

• Alcohol Use Disorder
• Substance Abuse
• Intimate Partner Violence Prevention

Approved in European Union as Motivational Enhancement Therapy for:

• Alcohol Use Disorder
• Substance Abuse

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Motivational Interviewing (MI) significantly improved adherence to positive airway pressure (PAP) therapy among naïve users with moderate-to-severe obstructive sleep apnea (OSA), increasing usage by 1-2.6 hours per night over 1 to 3 months.

In a meta-analysis of 10 trials involving 14 to 277 participants, MI showed a small to moderate effect on PAP adherence (Hedges' g = 0.38 to 0.48), but did not significantly benefit non-naïve users, indicating its effectiveness is primarily for those new to PAP therapy.

NCBI (Pubmed)

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. Crosby, ES., Spitzer, EG., Kavookjian, J.[2023]

In a study of 83 participants with moderate to severe obstructive sleep apnea (OSA), those receiving CPAP combined with motivational enhancement (ME) showed a significant increase in adherence, averaging 99 minutes more per night compared to those using CPAP alone over 6 months.

The positive impact of ME on CPAP adherence was consistent even after 12 months, suggesting that this approach could be an effective strategy for improving management of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Bakker, JP., Wang, R., Weng, J., et al.[2022]

Motivational interventions have been found to be more effective than usual care and educational programs in improving adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS), based on a review of 11 randomized controlled trials involving naïve CPAP users.

While these motivational strategies show promise in increasing adherence, the effects may not be consistently maintained over time, indicating a need for further research to understand the long-term impact and mechanisms of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving CPAP Adherence in Adults With Obstructive Sleep Apnea Syndrome: A Scoping Review of Motivational Interventions. Rapelli, G., Pietrabissa, G., Manzoni, GM., et al.[2023]

A motivational interviewing intervention (MINT) significantly improved CPAP adherence in patients with obstructive sleep apnoea, with the MINT group using CPAP for an average of 4.63 hours per night compared to 3.16 hours in the control group at the 3-month mark.

Patients receiving MINT were more likely to accept CPAP treatment, indicating that this brief intervention can effectively enhance both acceptance and adherence to CPAP therapy compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing (MINT) improves continuous positive airway pressure (CPAP) acceptance and adherence: a randomized controlled trial. Olsen, S., Smith, SS., Oei, TP., et al.[2022]

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]

An adaptive treatment strategy, starting with an educational intervention followed by either motivational enhancement or self-management for those with low PAP use, showed promise in improving adherence to positive airway pressure (PAP) therapy.

Participants in the study experienced significant increases in PAP usage, better sleep quality, and reduced daytime sleepiness, indicating the clinical significance of the interventions.

NCBI (Pubmed)

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. Cvengros, JA., Rodríguez, VM., Snyder, S., et al.[2018]

Positive airway pressure (PAP) therapy is the gold standard treatment for moderate to severe sleep apnea, significantly improving daytime sleepiness and cardiovascular health compared to conservative treatments.

To enhance patient adherence to PAP therapy, advanced features for comfort and humidity are being implemented, along with motivational strategies like interviews and desensitization protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]