Metabolism and Sleep Apnea Treatment

NCT05539716 | Recruiting FDA Device

• 2 other identifiers: 202106705R01HL146709-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.

Conditions

Obstructive Sleep Apnea; Fat Disorder

Outcome Measures

Primary Outcomes (1)

• Whole body lipolysis rate

  Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months

  Up to 3 months

Secondary Outcomes (8)

• Free Fatty Acids (FFA) Oxidation Rate

  Up to 3 months

• Adipocyte insulin resistance

  Up to 3 months

• Lipolysis suppression slope

  Up to 3 months

• Free fatty acid rebound slope

  Up to 3 months

• Free fatty acid insulin sensitivity parameter

  Up to 3 months

Study Arms (3)

No Intervention (Aim 1) Group

NO 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.

PAP Therapy and Lifestyle Intervention (Aim 2) Group

EXPERIMENTAL

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.

Device: PAP Therapy; Behavioral: Lifestyle Counseling Intervention

Lifestyle Intervention Only (Aim 2) Group

EXPERIMENTAL

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.

Behavioral: Lifestyle Counseling Intervention

Interventions

PAP Therapy DEVICE

Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use

PAP Therapy and Lifestyle Intervention (Aim 2) Group

Lifestyle Counseling Intervention BEHAVIORAL

Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene

Lifestyle Intervention Only (Aim 2) Group; PAP Therapy and Lifestyle Intervention (Aim 2) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-70 years
• Ability to provide consent

You may not qualify if:

• Body Mass Index (BMI) \> 40 kg/m2
• Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
• Type 1 or Type 2 diabetes mellitus
• Current or prior use of PAP or oral appliance therapy for OSA
• Use of oral corticosteroids
• 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)
• Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
• Use of supplemental oxygen during wakefulness or sleep
• Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
• Resting awake Oxygen Saturation (SpO2) \< 90%
• Aim 2 Group:
• Age between 18-70 years
• Ability to provide consent
• Moderate-to-severe OSA (AHI ≥ 15/h);
• Demonstration of Positive Airway Pressure (PAP) use of \> 4 h/night on 70% of the nights during 1-week run-in period

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33143, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Naresh Punjabi, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naresh Punjabi, MD

CONTACT

305-243-3963; npunjabi@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: September 14, 2022
• Study Start: May 20, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)