NCT06047496 · University of California, San Diego
Time Restricted Eating in Sleep Apnea
(TERESA)
What this study is about
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.
View original scientific 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.
Interventions
BEHAVIORAL
Time restricted eating
Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.
Primary outcome measures
Effect of TRE vs SE on change in mean daily glucose level
Time frame: 12 weeks
Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.
Effect of TRE vs SE on change in serum LDL cholesterol
Time frame: 12 weeks
Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.
Effect of TRE vs SE on change in OSA severity
Time frame: 12 weeks
Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.
Effect of TRE on quality of life
Time frame: 12 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2024 · Source of record for eligibility and locations