NCT05539716

Metabolism and Sleep Apnea Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	PAP Therapy	Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
BEHAVIORAL	Lifestyle Counseling Intervention	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

Timeline

• Start date: 2022-05-20
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2022-09-14
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study