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Behavioral Intervention
Time Restricted Eating for Sleep Apnea (TERESA Trial)
Phase < 1
Recruiting
Led By Omar Mesarwi, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr);
Be of appropriate age (18-70);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate the effects of a specific eating pattern called time restricted eating (TRE) on patients with obstructive sleep apnea (OSA). OSA is a common disorder that can
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly mentioned, potential side effects may include hunger, fatigue, or irritability due to changes in eating patterns. Changes in metabolism could also affect energy levels and mood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe sleep apnea that hasn't been treated.
Select...
I am between 18 and 70 years old.
Select...
I am on heart or blood pressure medication and won't change the dose during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of TRE on quality of life
Effect of TRE vs SE on change in OSA severity
Effect of TRE vs SE on change in mean daily glucose level
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eatingExperimental Treatment1 Intervention
Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.
Group II: Standard eatingActive Control1 Intervention
Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2021
N/A
~130
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,967 Total Patients Enrolled
Omar Mesarwi, MDPrincipal InvestigatorUniversity of California, San Diego
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