Status:
RECRUITING
Time Restricted Eating in Sleep Apnea
Lead Sponsor:
University of California, San Diego
Conditions:
Time Restricted Eating
Obstructive Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief 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, o...
Detailed Description
This study involves several visits: 1\. Those participants who fulfill inclusion criteria and are not excluded by virtue of any of the exclusion criteria will be asked to come to the University of Ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06047496
Start Date
January 5 2024
End Date
December 1 2028
Last Update
January 16 2024
Active Locations (1)
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1
University of California San Diego (ACTRI)
La Jolla, California, United States, 92037