RECRUITING

Time Restricted Eating in Sleep Apnea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Time Restricted Eating in Sleep Apnea Study

Quick Facts

Study Start:2024-01-05
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06047496

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form;
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study;
  3. * Be of appropriate age (18-70);
  4. * Own a smartphone (Apple iOS or Android OS);
  5. * Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
  6. * 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;
  7. * Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and
  8. * Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]
  1. * Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
  2. * 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
  3. * BMI \>40 kg/m2
  4. * Uncontrolled hypertension
  5. * Active tobacco or illicit drug use
  6. * Pregnant or breastfeeding women
  7. * Currently enrolled in a weight-loss or weight-management program
  8. * Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
  9. * Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
  10. * History of eating disorder(s)
  11. * History of surgical intervention for weight management
  12. * Chronic kidney disease
  13. * Treatment for active inflammatory and/or rheumatologic disease and cancer
  14. * Unrevascularized cardiovascular disease
  15. * Liver cirrhosis and/or significant alterations in liver function
  16. * 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)
  17. * Shift workers with variable (e.g., occasionally nocturnal) hours
  18. * Traveling outside the US
  19. * History of HIV/AIDS
  20. * Uncontrolled psychiatric disorder
  21. * Other safety concern based on MD judgement

Contacts and Locations

Study Contact

Pamela DeYoung, RPSGT
CONTACT
(858) 246-2154
pdeyoung@health.ucsd.edu
Omar Mesarwi, MD
CONTACT
(858) 822-1783
omesarwi@health.ucsd.edu

Principal Investigator

Omar Mesarwi, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California San Diego (ACTRI)
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Omar Mesarwi, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

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

Study Start Date2024-01-05
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • hyperglycemia
  • intermittent fasting
  • sleep apnea
  • weight loss
  • hyperlipidemia
  • metabolic syndrome

Additional Relevant MeSH Terms

  • Time Restricted Eating
  • Obstructive Sleep Apnea