Time Restricted Eating in Sleep Apnea
Eligible age
18–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ 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\]
You may not qualify if…
- ✕ Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
- ✕ OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
- ✕ BMI \>40 kg/m2
- ✕ Uncontrolled hypertension
- ✕ Active tobacco or illicit drug use
- ✕ Pregnant or breastfeeding women
- ✕ Currently enrolled in a weight-loss or weight-management program
- ✕ Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
Where it's recruiting
La Jolla
Source: ClinicalTrials.gov · NCT06047496 · last updated 2024-01-16