Clock Misalignment for Sleep Deprivation

(N-Sync Trial)

Overseen By Victoria Miranda, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Prescription medications

Disqualifiers: Sleep disorder, Heart disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 15 days

What You Need to Know Before You Apply

What is the purpose of this trial?

Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a person's metabolism (how the body breaks down food) when sleeping is reduced.

Participants will attend 6 to 8 in-person visits to the study clinic, including three overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months.

Who Is on the Research Team?

Christopher Depner, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-35 with a BMI of 18.5-24.9 who usually sleep 7-9 hours nightly. It's not suitable for those outside this age and BMI range or with different sleeping habits.

Inclusion Criteria

I am between 18 and 35 years old.

My BMI is between 18.5 and 24.9.

I usually sleep between 7 to 9 hours each night for the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Monitoring

Participants undergo a ~2-week ambulatory real-world monitoring segment prior to each in-lab sleep restriction condition

2 weeks

Treatment

Participants complete three arms of 5 nights of experimental sleep restriction under different conditions, followed by a constant routine protocol

15 days

6 to 8 visits (in-person), including three overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment, including an intravenous glucose tolerance test to analyze insulin sensitivity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Central Clock Misalignment
• Peripheral Misalignment

Trial Overview

The study examines how light exposure and meal timing affect metabolism when sleep is reduced, involving surveys, medical tests, and three overnight stays at the clinic over a period of 4 to 6 months.

How Is the Trial Designed?

Group I: Sleep Restriction with Peripheral Misalignment Experimental Treatment 1 Intervention

(Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours.

Group II: Sleep Restriction with Central Clock Misalignment Experimental Treatment 1 Intervention

(Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours.

Group III: Sleep Restriction with Central and Peripheral Alignment Active Control 1 Intervention

(Arm "A")-Control condition with central and peripheral aligned circadian rhythms

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+