Time Restricted Eating for Patients with Sleep Apnea
The Time Restricted Eating in Sleep Apnea Study
This study is testing if a new eating schedule can help people with sleep apnea improve their metabolism and overall health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06047496 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with untreated moderate to severe obstructive sleep apnea and a baseline eating period of at least 12 hours per day.
Not a fit: Patients with diabetes requiring insulin or sulfonylureas, or those with significant sleepiness due to OSA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve metabolic health and overall quality of life for patients with obstructive sleep apnea.
How similar studies have performed: While some human studies have shown improvements in metabolic dysfunction with time restricted eating, this specific application in OSA has not been previously examined.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Jolla, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.