Time Restricted Eating for Patients with Sleep Apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of time restricted eating (TRE) on metabolic dysfunction in patients with obstructive sleep apnea (OSA). Participants will undergo a baseline period where they will log their dietary intake using a mobile app and wear a continuous glucose monitor. Following this, they will be randomized to implement TRE to assess its impact on glucose and lipid metabolism. The study aims to provide insights into alternative therapies for managing metabolic issues associated with OSA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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\]

Exclusion Criteria:

* 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's running

• University of California San Diego (ACTRI)
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Omar Mesarwi, MD — University of California, San Diego
• Study coordinator: Pamela DeYoung, RPSGT
• Email: pdeyoung@health.ucsd.edu
• Phone: (858) 246-2154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.