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Behavioral Intervention

Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea (MaST Trial)

N/A

Recruiting

Led By Naresh Punjabi, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstration of Positive Airway Pressure (PAP) use of > 4 h/night on 70% of the nights during 1-week run-in period

Moderate-to-severe OSA (AHI ≥ 15/h)

Must not have

Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)

Current or prior use of PAP or oral appliance therapy for OSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn if obstructive sleep apnea is linked to abnormalities in fat metabolism.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the document doesn't list specific side effects, generally PAP therapy may cause discomfort, nasal congestion, dry mouth, or skin irritation where the mask touches the face. Lifestyle counseling typically does not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have moderate-to-severe sleep apnea.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have diabetes (Type 1 or Type 2).

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I use supplemental oxygen when awake or asleep.

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I have had a car accident or near-miss because of sleepiness in the last 2 years.

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I have a history of heart attack, heart surgery, heart failure, or stroke.

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I have been diagnosed with a specific sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Whole body lipolysis rate

Secondary study objectives

Acute insulin response to glucose

Adipocyte insulin resistance

Free Fatty Acids (FFA) Oxidation Rate

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PAP Therapy and Lifestyle Intervention (Aim 2) GroupExperimental Treatment2 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) GroupExperimental Treatment1 Intervention

Group III: No Intervention (Aim 1) GroupActive Control1 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.

0 / 10Eligibility criteria met