Metabolism and Sleep Apnea Treatment

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05539716
Status
Recruiting
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Conditions

  • Fat Disorder
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

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
  • 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

Study Details

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.

Key Dates

Start date
May 20, 2022
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: No Intervention (Aim 1) Group
    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.
  • Experimental: PAP Therapy and Lifestyle Intervention (Aim 2) Group
    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.
  • Experimental: Lifestyle Intervention Only (Aim 2) Group
    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.

Primary Outcome Measure

Whole body lipolysis rate [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33143
Naresh Punjabi, MD
[email protected]
305-243-3963
Naresh Punjabi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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