RECRUITING
I'm interested ...!!
Time Restricted Eating in Sleep Apnea
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:
🦠 Time Restricted Eating 🦠 Obstructive Sleep Apnea
🗓️ Study Start (Actual) 5 January 2024
🗓️ Primary Completion (Estimated) July 2027
✅ Study Completion (Estimated) December 2028
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 La Jolla, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 August 2023
  • First Submitted that Met QC Criteria 14 September 2023
  • First Posted 21 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 January 2024
  • Last Update Posted 16 January 2024
  • Last Verified January 2024
I'm interested ...!!