The Time Restricted Eating in Sleep Apnea Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. While continuous positive airway pressure (CPAP), the best available OSA treatment, has been shown to improve blood pressure in OSA, it does not appear to improve metabolic consequences of OSA, and other therapies for OSA-induced dysmetabolism are needed. Animal models of time restricted eating (TRE) demonstrate an improvement in glucose and lipid metabolism, even in the absence of a reduction of caloric intake. Some human studies have shown an improvement in metabolic dysfunction with TRE, though further well-designed studies are needed. The effects of TRE on metabolic dysfunction in patients with OSA, a population with a high predisposition to metabolic disorder, has never been examined. In this study, we will conduct a randomized clinical trial to assess the feasibility and efficacy of 12 weeks of TRE, versus standard eating (SE), to improve glucose regulation and cardiovascular health of participants with OSA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form;

• Stated willingness to comply with all study procedures and availability for the duration of the study;

• Be of appropriate age (18-70);

• Own a smartphone (Apple iOS or Android OS);

• Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;

• If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period;

• Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and

• Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Locations
United States
California
University of California San Diego (ACTRI)
RECRUITING
La Jolla
Contact Information
Primary
Pamela DeYoung, RPSGT
pdeyoung@health.ucsd.edu
(858) 246-2154
Backup
Omar Mesarwi, MD
omesarwi@health.ucsd.edu
(858) 822-1783
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 80
Treatments
Experimental: Time restricted eating
Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.
No_intervention: Standard eating
Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov

Similar Clinical Trials