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Time Restricted Eating in Sleep Apnea

ConditionsTime Restricted EatingObstructive 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Time restricted eating

    Behavioral

    Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Time restricted eatingExperimental treatment 1 intervention
Group B: Standard eatingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Effect of TRE vs SE on change in mean daily glucose level

Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.

Time frame
12 weeks
2

Effect of TRE vs SE on change in serum LDL cholesterol

Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.

Time frame
12 weeks
3

Effect of TRE vs SE on change in OSA severity

Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.

Time frame
12 weeks
4

Effect of TRE on quality of life

Change in quality of life, based on the Short Form (36) Health Survey, will be compared in TRE and SE groups. This survey is a patient-reported scale measuring overall health. It features eight scaled scores, where the scores are the weighted sums in each section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores range from 0-100 where lower scores mean more disability, and higher scores mean higher disability.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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