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New treatment option for Time Restricted Eating
Official title Time Restricted Eating in Sleep Apnea
ClinicalTrials.gov ID: NCT06047496
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia...
- OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive...
- BMI \>40 kg/m2
- Uncontrolled hypertension
- Active tobacco or illicit drug use
- Pregnant or breastfeeding women
See the full eligibility 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]
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.