Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea

(MaST Trial)

Overseen By Naresh Punjabi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Oral corticosteroids

Disqualifiers: Diabetes, Heart failure, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how obstructive sleep apnea (OSA) affects the body's processing of fat, energy, and sugar. It examines whether lifestyle counseling alone or combined with PAP therapy (a machine that aids nighttime breathing) can make a difference. Individuals with moderate to severe OSA who have not previously used PAP therapy may be suitable candidates. This trial may interest those experiencing frequent breathing interruptions during sleep and seeking potential treatment benefits. As an unphased trial, it offers a unique opportunity to contribute to understanding OSA treatments and their effects on energy and sugar processing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use oral corticosteroids or have unstable medical conditions. It's best to discuss your specific medications with the trial team.

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

Research has shown that both lifestyle counseling and PAP (Positive Airway Pressure) therapy are generally safe for treating obstructive sleep apnea. Studies indicate that lifestyle changes, such as losing weight, quitting smoking, and exercising, can significantly improve sleep apnea symptoms without major safety concerns.

PAP therapy is commonly used and considered safe, though some individuals might experience minor side effects like a stuffy nose or dry mouth. It has proven effective in reducing the severity of sleep apnea and improving overall health, such as lowering blood pressure. Both treatments have a strong safety record, offering reassurance to those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obstructive sleep apnea (OSA) because they combine lifestyle counseling with PAP (Positive Airway Pressure) therapy, offering a comprehensive approach that addresses both behavioral and physical aspects of the condition. Unlike standard treatments that typically focus solely on PAP therapy to maintain airway patency during sleep, this approach adds personalized lifestyle changes, which can potentially enhance overall adherence and long-term outcomes. Additionally, examining the effects of lifestyle counseling alone provides insights into non-device-based strategies, offering options for patients who may struggle with PAP therapy compliance. This dual approach might lead to more sustainable improvements in sleep quality and overall health.

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

Research shows that lifestyle counseling, which often includes weight loss and dietary changes, can greatly help with obstructive sleep apnea (OSA). Studies have found that these changes can lead to better outcomes for OSA, with many people experiencing less severe symptoms. For example, one study found that 40% of participants in a lifestyle program improved their OSA from severe to moderate or mild. In this trial, some participants will receive only the Lifestyle Counseling Intervention.

Positive Airway Pressure (PAP) therapy is a well-known treatment for OSA. Evidence shows that PAP therapy effectively reduces the severity of the condition and improves symptoms like daytime sleepiness. It also helps lower blood pressure and boosts overall health. PAP therapy is considered a standard treatment due to its strong history of successfully managing OSA symptoms. In this trial, another group of participants will receive both PAP therapy and the Lifestyle Counseling Intervention. ^{3 5 6 7 8}

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 aged 18-70 with moderate-to-severe obstructive sleep apnea who can use a PAP device for at least 4 hours on most nights. It's not for those with diabetes, severe heart conditions, certain sleep disorders, or a BMI over 40. Participants should not be using other OSA treatments or involved in another clinical study.

Inclusion Criteria

I use a CPAP machine for more than 4 hours a night, most nights.

I have moderate-to-severe sleep apnea.

Ability to provide consent

Exclusion Criteria

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

I use or have used a CPAP machine or oral appliance for sleep apnea.

I have diabetes (Type 1 or Type 2).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks

Several testing procedures

Treatment

Participants receive Lifestyle Intervention and/or PAP therapy for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Counseling Intervention
• PAP Therapy

Trial Overview The study looks at how fat metabolism might be different in people with obstructive sleep apnea compared to those without it. It involves lifestyle counseling and the use of Positive Airway Pressure (PAP) therapy to see if these interventions affect body energy and sugar usage.

How Is the Trial Designed?

Group I: PAP Therapy and Lifestyle Intervention (Aim 2) Group Experimental Treatment 2 Interventions

Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.

Group II: Lifestyle Intervention Only (Aim 2) Group Experimental Treatment 1 Intervention

Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.

Group III: No Intervention (Aim 1) Group Active Control 1 Intervention

Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.

Lifestyle Counseling Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Counseling Intervention for:

• Obstructive Sleep Apnea (OSA)

Approved in European Union as Lifestyle Counseling Intervention for:

• Obstructive Sleep Apnea (OSA)
• Sleep Disorders

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Continuous positive airway pressure (CPAP) therapy is a key treatment for obstructive sleep apnea syndrome (OSAS), and advancements in technology are enhancing its delivery and effectiveness.

The article reviews various treatment options for OSAS, including non-PAP methods like oral appliances and lifestyle changes, highlighting the importance of improving patient compliance with CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea syndrome. Freedman, N.[2010]

Positive airway pressure (PAP) therapy is the first-line treatment for moderate to severe obstructive sleep apnea and can also be beneficial for mild cases, especially when symptoms are present or there are cardiovascular issues.

Despite its proven effectiveness in treating obstructive sleep apnea, many patients struggle with adherence to PAP therapy, highlighting the need for ongoing follow-up to ensure treatment effectiveness and encourage compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Airway Pressure Therapy for Obstructive Sleep Apnea. Weiss, P., Kryger, M.[2017]

Nonadherence to positive airway pressure (PAP) therapy for obstructive sleep apnea (OSA) can lead to increased sleepiness and a higher risk of cardiovascular issues, highlighting the importance of consistent use for health outcomes.

Factors such as being asymptomatic, nasal obstruction, low self-efficacy, and lower socioeconomic status are linked to poor adherence, but interventions like cognitive-behavioral therapy and education can help improve adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to positive airway pressure therapy in adults and children. Archbold, KH., Parthasarathy, S.[2012]

Traditional medical training often focuses on an expert approach, which is less effective for managing chronic diseases compared to a coaching approach that empowers patients to reflect on their motivations and obstacles for behavior change.

The coaching approach involves active collaboration between practitioners and patients, utilizing techniques like mindful listening and open-ended questions, which can lead to better self-discovery and responsibility in achieving healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration and Negotiation: The Key to Therapeutic Lifestyle Change. Frates, EP., Bonnet, J.[2023]

Many people struggle to follow dietary and exercise recommendations, indicating that current lifestyle counseling may not be effectively reaching its goals, despite being considered essential in medical care.

Research suggests that both conscious and automatic psychosocial processes can support behavior change, and there is growing evidence that automated processes may enhance the effectiveness of lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. Absetz, P., Hankonen, N.[2018]

About one third of adults in Germany aged 30 to 69 suffer from obstructive sleep apnea (OSA), which can lead to serious health issues like disturbed sleep and increased cardiovascular risks.

Positive airway pressure (PAP) therapy is effective for all severities of OSA, but alternative conservative treatments may be necessary for patients who cannot tolerate or do not respond to PAP therapy, emphasizing the need for personalized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conservative treatment of obstructive sleep apnea using non-PAP therapies]. Maurer, JT., Leitzbach, S.[2020]

Incorporating interpersonal communication skills, such as motivational interviewing and brief action planning (BAP), can significantly enhance lifestyle medicine practices by helping patients adopt and maintain healthier behaviors like improved diet and exercise.

Motivational interviewing focuses on engaging patients through empathy and active listening, while BAP provides a structured approach for setting specific, achievable health goals, making it easier for patients to commit to and follow through on their health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using motivational interviewing and brief action planning for adopting and maintaining positive health behaviors. Cole, SA., Sannidhi, D., Jadotte, YT., et al.[2023]

Behavioral counseling can significantly enhance adherence to healthy lifestyle changes, which is crucial for reaping the associated health benefits.

Understanding individual motivation and resistance to change is essential for effective counseling, and established models like motivational interviewing and the transtheoretical model can be applied to encourage increased physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Counseling to Promote Adherence in Healthy Lifestyle Medicine: Strategies to Improve Exercise Adherence and Enhance Physical Activity. Stonerock, GL., Blumenthal, JA.[2023]

Successful counseling by physicians requires clear communication of actionable steps to patients and fostering their commitment to behavior change.

Integrating behavioral strategies within a supportive primary care team can enhance patient outcomes by ensuring ongoing support and follow-up for lasting behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating patient participation: the doctor-patient encounter. Stoffelmayr, B., Hoppe, RB., Weber, N.[2005]

Lifestyle counseling is effective in managing chronic diseases and improving satisfaction for both patients and providers, but challenges remain in implementing and maintaining these changes.

The case study demonstrates that motivational interviewing can be a practical strategy used during office visits to help patients identify and achieve their health goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling patients for lifestyle change: making a 15-minute office visit work. Berra, K., Hughes, S.[2015]

EPAP nasal devices are a promising treatment for obstructive sleep apnea (OSA), showing a reduction in the apnea/hypopnea index (AHI) and daytime sleepiness, with patients generally preferring them over CPAP.

While CPAP is more effective for improving sleep apnea, EPAP can provide similar symptom relief for patients with mild to moderate OSA who cannot tolerate CPAP, although more well-designed clinical trials are needed to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. Wu, H., Yuan, X., Zhan, X., et al.[2021]

A brief 1- to 3-minute discussion by family physicians about the risks of unhealthy lifestyles effectively helps patients recognize their personal health risks and motivates them to make lifestyle changes.

An office-based counseling model for physicians, which includes assessing patients, discussing risks, prescribing behavior change strategies, and maintaining progress, has been shown to successfully encourage older patients to adopt healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthier lifestyles: how to motivate older patients to change. Sennott-Miller, L., Kligman, EW.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3773205/

Effectiveness of Lifestyle Interventions on Obstructive Sleep ... Conclusions: Published evidence suggests that weight loss through lifestyle and dietary interventions results in improvements in obstructive sleep apnea ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6133123/

Improvement in obstructive sleep apnea after a tailored ... In ExpG, 40% (n = 14) had improved from severe to moderate or mild OSA or from moderate to mild OSA compared to 16.7% in CG (n = 6, p = 0.02). Further, a lower ...

3. 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 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2791455

Effect of an Interdisciplinary Weight Loss and Lifestyle ... An 8-week interdisciplinary weight loss and lifestyle intervention significantly improved OSA severity and other outcomes compared with usual care alone.

5. mdpi.com mdpi.com/2075-1729/13/8/1755

A Dietary and Lifestyle Intervention Improves Treatment ... Lifestyle-induced weight loss has been extensively investigated as a treatment approach to reverse OSA pathogenesis and is effective in improvement in both OSA ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06382883

Lifestyle and Physical Activity as Part Of Obstructive Sleep ... The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7920220/

Cultivating Lifestyle Transformations in Obstructive Sleep Apnea Reducing weight, quitting alcohol and smoking, eating a nutritional diet, and exercising are the modifications to benefit people.

8. withpower.com withpower.com/trial/phase-apnea-9-2022-d47f0

Lifestyle Counseling + PAP Therapy for Obstructive Sleep ... PAP therapy, including CPAP, BiPAP, and APAP, is widely used for treating sleep apnea and is generally safe, though some people may experience minor side ...