Actively Recruiting
Time Restricted Eating in Sleep Apnea
Led by University of California, San Diego · Updated on 2024-01-16
80
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time Restricted Eating in Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the whole study
- Aged between 18 and 70 years
- Own a smartphone (Apple iOS or Android)
- Baseline eating period of 12 hours or more per day with sufficient logging on the myCircadianClock app
- If taking cardiovascular medications, no dose changes during the study
- Untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index 15 or more events/hour)
- Agree to follow lifestyle considerations throughout the study
You will not qualify if you...
- Type 1 or type 2 diabetes mellitus treated with insulin or sulfonylureas, or history of hypoglycemia unawareness
- Significant sleepiness from OSA (Epworth Sleepiness Score 15 or more, or motor vehicle accident due to sleepiness in past year)
- Body mass index (BMI) over 40 kg/m2
- Uncontrolled high blood pressure
- Active tobacco or illicit drug use
- Pregnant or breastfeeding
- Currently enrolled in weight-loss or weight-management program
- On a special or prescribed diet (e.g., for Celiac disease)
- Taking medications for weight loss or appetite suppression
- History of eating disorders
- History of weight management surgery
- Chronic kidney disease
- Treatment for active inflammatory, rheumatologic disease, or cancer
- Unrevascularized cardiovascular disease
- Liver cirrhosis or significant liver dysfunction
- Thyroid disease requiring recent dose changes of replacement medication
- Shift workers with variable hours
- Traveling outside the US
- History of HIV/AIDS
- Uncontrolled psychiatric disorder
- Other safety concerns judged by a doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California San Diego (ACTRI)
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
P
Pamela DeYoung, RPSGT
CONTACT
O
Omar Mesarwi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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