Time Restricted Eating in Sleep Apnea

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a method called Time Restricted Eating (TRE) can help improve health in people with obstructive sleep apnea (OSA). OSA is a condition that causes breathing problems during sleep and is linked to issues like high blood pressure, diabetes, and obesity. While the standard treatment for OSA is a device called CPAP that helps keep airways open during sleep, it doesn’t fully address the metabolic problems related to the condition. In this study, participants will follow a specific eating schedule for 12 weeks to see if it helps with blood sugar and heart health compared to regular eating habits.

To participate, individuals should be between 18 and 70 years old, have moderate to severe OSA, and own a smartphone to track their eating patterns using an app. Participants will need to commit to the study for its entire duration and be willing to follow certain lifestyle guidelines. Those with specific health issues, such as uncontrolled diabetes or severe obesity, or who are currently on certain medications, may not be eligible. Throughout the trial, participants will receive guidance and support to help them stick to the eating plan, and their health will be monitored to assess any changes. This study aims to provide valuable insights into how eating patterns can impact the health of individuals with OSA.

Gender

ALL

Eligibility 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