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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
MaST Trial 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.Check my eligibility
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.See study design
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.
MaST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use a CPAP machine for more than 4 hours a night, most nights.
Select...
I have moderate-to-severe sleep apnea.
Select...
I am between 18 and 70 years old.
MaST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Whole body lipolysis rate
Secondary outcome measures
Acute insulin response to glucose
Adipocyte insulin resistance
Free Fatty Acids (FFA) Oxidation Rate
+5 moreMaST 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
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) 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.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
900 Previous Clinical Trials
409,832 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,948 Total Patients Enrolled
Naresh Punjabi, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health conditions like uncontrolled heart issues, severe lung disease, or major depression.I use a CPAP machine for more than 4 hours a night, most nights.I have moderate-to-severe sleep apnea.I use or have used a CPAP machine or oral appliance for sleep apnea.I have diabetes (Type 1 or Type 2).I use supplemental oxygen when awake or asleep.I have had a car accident or near-miss because of sleepiness in the last 2 years.I have a history of heart attack, heart surgery, heart failure, or stroke.You have a score of 18 or more on the Epworth sleepiness test.I am taking oral corticosteroids.Your oxygen levels while resting and awake are below 90%.I have a sleep disorder or usually sleep less than 6 hours.I have been diagnosed with a specific sleep disorder.Your body mass index (BMI) is higher than 40.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: PAP Therapy and Lifestyle Intervention (Aim 2) Group
- Group 2: Lifestyle Intervention Only (Aim 2) Group
- Group 3: No Intervention (Aim 1) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to join this clinical investigation?
"This research endeavour is taking applications from 100 persons aged 18 to 70 who suffer from metabolic dyslipidemia. In addition, participants must be of age and able to provide informed consent."
Answered by AI
How many participants are being approved for inclusion in this research?
"Affirmative. According to clinicaltrials.gov, this healthcare investigation was initially posted on October 27th 2022 and recently revised on November 10th 2022. The trial is now accepting 100 participants across a single medical centre."
Answered by AI
Are individuals of advanced age being included in this clinical investigation?
"This medical study is recruiting individuals aged 18 and above, yet younger than 70."
Answered by AI
Are there still spots available in this experiment?
"This clinical trial, which was first made available on October 27 2022 is still actively seeking patients. The details of the study were last updated by researchers on November 10th 2022 according to Clinicaltrials.gov."
Answered by AI
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