Time Restricted Eating for Sleep Apnea

(TERESA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Omar Mesarwi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of California, San Diego

Must not be taking: Insulin, Sulfonylureas, Appetite suppressants, others

Disqualifiers: Diabetes, BMI >40, Hypertension, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on cardiovascular medications like statins or blood pressure drugs, you must keep the same dose during the study.

What data supports the effectiveness of the treatment Time Restricted Eating for Sleep Apnea?

Research suggests that time-restricted eating (TRE) can help reduce body weight and improve energy metabolism, which are factors that might indirectly benefit sleep apnea. Although direct effects on sleep apnea are not yet confirmed, TRE has been shown to maintain good sleep quality in people with obesity, which could be relevant for sleep apnea management. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Research suggests that time-restricted eating (TRE) is generally safe for humans, as studies have shown no significant adverse effects in adults with obesity over short periods. However, long-term safety data is limited, and more research is needed to confirm these findings. ^{4 6 7 8 9}

How is time-restricted eating different from other treatments for sleep apnea?

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, aligning with your body's natural circadian rhythms, rather than using medications or devices. This approach may help improve sleep quality and energy metabolism without affecting total energy expenditure, offering a novel way to manage sleep apnea by potentially reducing body weight and improving sleep patterns. ^{1 10 11 12 13}

Research Team

Omar Mesarwi, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adults aged 18-70 with untreated moderate to severe obstructive sleep apnea (OSA). Participants must be willing to follow the study procedures, own a smartphone, and have an eating period of over 12 hours per day. They cannot change doses of any cardiovascular medications during the study.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

I have moderate to severe sleep apnea that hasn't been treated.

You commit to following the Lifestyle Considerations throughout the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Participants maintain their current lifestyle and record dietary intake using the mCC app

2 weeks

1 visit (in-person)

Treatment

Participants follow either time restricted eating or standard eating for 12 weeks

12 weeks

6 visits (virtual), 2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Time Restricted Eating (Behavioral Intervention)

Trial Overview The trial is testing if time restricted eating (TRE) can improve glucose regulation and cardiovascular health in OSA patients compared to standard eating habits. It involves following a TRE plan for 12 weeks and uses smartphones for tracking.

Participant Groups

Group I: Time restricted eating Experimental Treatment 1 Intervention

Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.

Group II: Standard eating Active Control 1 Intervention

Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Findings from Research

In a study involving 15 healthy adults who typically sleep late, early time-restricted eating (eTRE) significantly advanced their sleep timing, with participants reporting an earlier sleep onset by an average of 56.1 minutes compared to a control group.

Both self-reported and objectively measured sleep metrics (onset, midpoint, and offset) improved with eTRE, suggesting it could be an effective clinical strategy for helping late sleepers adjust their sleep schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted eating advances sleep in late sleepers: a pilot randomized controlled trial. Blum, DJ., Hernandez, B., Zeitzer, JM.[2023]

In a study of 23 obese adults following an 8-hour time-restricted feeding (TRF) schedule for 12 weeks, sleep quality remained consistently good, as indicated by a Pittsburgh Sleep Quality Index score below 5 throughout the trial.

The research found that TRF did not change subjective measures of sleep duration or timing, suggesting that this dietary approach does not negatively impact sleep in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. Gabel, K., Hoddy, KK., Burgess, HJ., et al.[2020]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

A study involving 608 participants found that most people typically eat within a 10 to 14-hour window on both workdays and free days, indicating a common pattern of energy intake.

The likelihood of adopting time-restricted feeding (TRF) decreases as the proposed feeding window restriction increases, with key factors influencing this decision being cost, time availability, and perceived health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of factors influencing motivation to undertake time-restricted feeding in humans. Jefcoate, PW., Robertson, MD., Ogden, J., et al.[2021]

Time-restricted eating (TRE) is emerging as a promising strategy for treating obesity and related health issues, addressing the challenges of long-term adherence to traditional hypocaloric diets.

While TRE may help with weight loss and metabolic health through mechanisms like reduced caloric intake and improved eating behaviors, there are significant limitations in current research, including inconsistencies in clinical trials and a lack of long-term safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. Berkovskaya, MA., Gurova, OY., Khaykina, IA., et al.[2023]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Meal Timing and Sleeping Energy Metabolism. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early time-restricted eating advances sleep in late sleepers: a pilot randomized controlled trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Identification of factors influencing motivation to undertake time-restricted feeding in humans. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The effect of 4-h versus 6-h time restricted feeding on sleep quality, duration, insomnia severity and obstructive sleep apnea in adults with obesity. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. [2023]