Time Restricted Eating in Sleep Apnea

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Time restricted eating

Treatment groups

80 Participants
are divided into 2 treatment groups