Actively Recruiting
The Time Restricted Eating in Sleep Apnea Study A Randomized Trial Evaluating Metabolic and Cardiovascular Effects Of Time Restricted Eating Versus Standard Eating in Adults With Obstructive Sleep Apnea
Led by University of California, San Diego · Updated on 2024-01-16
80
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of time restricted eating (TRE) on people with obstructive sleep apnea (OSA), a condition linked to heart and metabolic problems like high blood pressure, diabetes, and obesity. While the current OSA treatment, continuous positive airway pressure (CPAP), helps with blood pressure, it does not improve metabolic issues. This trial aims to see if limiting eating to a 10-hour daily window for 12 weeks can improve blood sugar control, cholesterol, sleep apnea severity, and quality of life compared to usual eating habits. Participants will be randomly assigned to either a TRE group, where they limit all calorie intake to a self-chosen 8-10 hour period each day for 12 weeks, or a standard eating group that continues their normal diet. Before the intervention, participants undergo a 2-week baseline period wearing a continuous glucose monitor and an activity watch while logging their food intake using a smartphone app. During the 12-week intervention, participants continue to track food and have biweekly virtual check-ins. At weeks 10 and 12, additional monitoring and assessments occur including sleep apnea testing and blood draws. Throughout the study, participants complete questionnaires, dietary recalls, blood tests, and wear devices to monitor glucose and activity. The study measures changes in daily glucose levels, LDL cholesterol, OSA severity, and quality of life after 12 weeks. Participants provide feedback on their experience, and researchers monitor adherence and safety. The study lasts about 14 weeks including baseline and intervention periods with ongoing support and data collection.
CONDITIONS
Brief Title
Time Restricted Eating in Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Willingness to follow all study procedures and be available for the study duration.
- Aged between 18 and 70 years.
- Own a smartphone with Apple iOS or Android OS.
- Baseline eating period of 12 hours or more per day with sufficient logging on the myCircadianClock app.
- Stable dose of cardiovascular medications if used (no dose changes allowed during study).
- Untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index 15 or more events per hour).
- Agree to follow lifestyle considerations during the study.
You will not qualify if you...
- Type 1 or type 2 diabetes treated with insulin or sulfonylureas, or history of hypoglycemia unawareness.
- Significant sleepiness due to OSA (Epworth Sleepiness Score 15 or more or motor vehicle accident from sleepiness in past year).
- Body mass index over 40 kg/m2.
- Uncontrolled hypertension.
- Active tobacco or illicit drug use.
- Pregnant or breastfeeding women.
- Currently enrolled in weight-loss or weight-management programs.
- On a special or prescribed diet for other reasons (e.g., Celiac disease).
- Taking medications for weight loss or appetite suppression.
- History of eating disorders or weight management surgery.
- Chronic kidney disease.
- Active inflammatory, rheumatologic disease or cancer treatment.
- Unrevascularized cardiovascular disease.
- Liver cirrhosis or significant liver function issues.
- Thyroid disease requiring recent dose changes (stable hypothyroidism allowed).
- Shift workers with variable hours.
- Traveling outside the US.
- History of HIV/AIDS.
- Uncontrolled psychiatric disorders.
- Other safety concerns as judged by a doctor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the start of screening and 1 visit (in-person) at the end of screening
Duration - 12 weeks
Participants follow either a time restricted eating schedule or continue their standard eating routine, while logging all food and beverage intake using the myCircadianClock app. They receive regular support and monitoring from the research team.
Biweekly phone or video visits and 2 in-person visits at weeks 10 and 12
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
O
Omar Mesarwi, MD
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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