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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate adherence to Positive Airway Pressure (PAP) therapy when participants receive additional support through motivational talks. It targets individuals with moderate-to-severe obstructive sleep apnea (OSA), a condition characterized by interrupted breathing during sleep. The study compares participants receiving motivational support alongside standard care to those receiving only standard care. Individuals with moderate-to-severe OSA who have never used PAP therapy are suitable candidates for this trial. As an unphased trial, it provides a unique opportunity to explore new methods for improving adherence to PAP therapy with additional support.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Motivational Enhancement Therapy (MET) is generally well-tolerated for helping people adhere to their positive airway pressure (PAP) therapy. Studies have found that patients receiving MET effectively followed their PAP treatment, suggesting that MET helps them stay on track without major issues.

MET increases motivation to use PAP therapy, the standard treatment for obstructive sleep apnea (OSA). Significant side effects from MET have not been reported, which is reassuring for those considering participation in a trial with this therapy.

Overall, MET is considered safe and useful for individuals dealing with OSA. Prospective participants can feel confident about the treatment's safety based on these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the combination of Motivational Enhancement Therapy (MET) with Positive Airway Pressure (PAP) therapy for obstructive sleep apnea. Unlike the standard PAP therapy, which solely focuses on maintaining open airways during sleep, MET aims to boost patient motivation and adherence to the treatment. By enhancing patient commitment, this approach could improve treatment outcomes and address the common issue of low compliance with PAP therapy.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

This trial will compare Motivational Enhancement Therapy (MET) combined with Positive Airway Pressure (PAP) therapy to PAP therapy alone for obstructive sleep apnea (OSA). Research has shown that MET can help people consistently use their PAP machines by helping patients find personal reasons to adhere to their treatment, increasing usage frequency. One study found that motivational interviewing techniques improved patient adherence to treatment plans. These techniques help patients better understand their condition and feel more motivated to use their treatment regularly. Overall, MET shows promise in helping people with OSA maximize the benefits of their PAP therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Naresh Punjabi, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4980541/

Motivational Enhancement for Increasing Adherence to CPAP Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA. We performed an open-label, parallel-arm, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2659663621000072

MEntA Program Based on Motivational Interview to ... The aim of this study was to determine whether an educational and training program based on motivational interviewing and proper feedback, improved adherence.

3. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000210932

Group Motivational Interviewing to Improve Sleep Apnea ... Current literature has shown that MI can be effective in improving APAP adherence. We aimed to increase our APAP adherence in newly diagnosed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3792382/

Motivational Enhancement to Improve Adherence to Positive ... The aim of the current study is to test two treatments versus standard care in improving adherence to PAP.

5. journal.chestnet.org journal.chestnet.org/article/S0012-3692(16)45716-8/abstract

Motivational Enhancement for Increasing Adherence to CPAP Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA. Methods. We performed an open-label, parallel-arm, randomized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10369649/

MEntA Program Based on Motivational Interview to Improve ... The MEntA intervention included as part of an educational and training program for patients with OSA with CPAP therapy shows solid results in terms of its ...

7. academic.oup.com academic.oup.com/sleep/article/36/11/1655/2558942

A Randomized Controlled Trial | SLEEP | Oxford Academic Two hundred twenty-seven patients with OSA were randomized to standard care (SC), education (ED) and motivational enhancement therapy (MET). Adherence was ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.947296/full

Study protocol of a randomized controlled trial ... This study aims to evaluate the effectiveness of the MotivAir program—a phone-based intervention based on Motivational Interviewing (MI) ...

9. sleep.org.au sleep.org.au/common/Uploaded%20files/Public%20Files/Resources/MI_CPAP_Manual.pdf

Motivational Interviewing to Improve CPAP Therapy ... This manual is designed to be used by CPAP therapists to enhance motivation for treatment use for patients commencing CPAP (Continuous Positive Airways Pressure) ...