Time Restricted Eating in Sleep Apnea

Recruiting now · Early Phase 1

Conditions studied: Time Restricted Eating, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID: NCT06047496
Run by: University of California, San Diego
People needed: 80
Starts: 2024-01-05
Expected to finish: 2028-12-01
Last updated by the study team: 2024-01-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)
Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
History of eating disorder(s)
History of surgical intervention for weight management
Chronic kidney disease
Treatment for active inflammatory and/or rheumatologic disease and cancer
Unrevascularized cardiovascular disease
Liver cirrhosis and/or significant alterations in liver function
History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
Shift workers with variable (e.g., occasionally nocturnal) hours
Traveling outside the US
History of HIV/AIDS
Uncontrolled psychiatric disorder
Other safety concern based on MD judgement

Where it is running

University of California San Diego (ACTRI) — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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