Early Phase 1 Sleep Disorders Trial, Recruiting NCT06047496 Sponsor: University of California, San Diego Condition: Sleep Disorders
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Early Phase 1 Sleep Disorders Trial, Recruiting

NCT06047496
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 70 years old
  • You are willing to sign a consent form and follow all study requirements for the full duration of the trial
  • You own a smartphone (iPhone or Android)
  • You currently eat across a window of 12 hours or more per day, and are able to log your eating using the myCircadianClock app
  • You have been diagnosed with moderate to severe obstructive sleep apnea (a sleep condition where breathing repeatedly stops during sleep) that is not currently being treated
  • If you take certain heart or cholesterol medications (such as statins, other cholesterol-lowering drugs, or blood pressure medications), you agree not to change your dose during the study
  • You agree to follow the lifestyle guidelines set out by the study for its full duration

Who may not be able to join:

  • You have type 1 or type 2 diabetes and take insulin or sulfonylurea medications, or you have ever had a low blood sugar episode without being aware of it
  • You have sleep apnea and also experience significant daytime sleepiness, either scoring 15 or higher on a standard sleepiness questionnaire, or having been in a car accident due to excessive sleepiness in the past year
  • Your BMI (a measure of body weight relative to height) is over 40
  • You have high blood pressure that is not well controlled
  • You currently smoke or use illicit drugs
  • You are pregnant or breastfeeding
  • You are currently taking part in a weight-loss or weight-management program
  • You are currently following a special or medically prescribed diet (for example, for Celiac disease)
  • You are currently taking any medication intended for weight loss or known to reduce appetite
  • You have a history of an eating disorder
  • You have previously had surgery for weight management
  • You have chronic kidney disease
  • You are currently being treated for an active inflammatory condition, rheumatologic (joint/immune) disease, or cancer
  • You have heart or artery disease that has not been treated with a procedure to restore blood flow
  • You have liver cirrhosis or significantly abnormal liver function
  • You have a thyroid condition that required a change in your thyroid medication dose within the past 3 months (note: having hypothyroidism on a stable, unchanged dose does not exclude you — confirm with trial site)
  • You work shift work with variable hours, including occasional night shifts
  • You are planning to travel outside the United States during the study
  • You have a history of HIV/AIDS
  • You have a psychiatric condition that is not well controlled
  • A study doctor has another safety concern about your participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
5 January 2024
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Effect of TRE vs SE on change in mean daily glucose level; Effect of TRE vs SE on change in serum LDL cholesterol; Effect of TRE vs SE on change in OSA severity; Effect of TRE on quality of life

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov