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Improved Sleep for Obesity and Diabetes Risk Reduction

N/A
Recruiting
Led By Erin Hanlon, Ph.D.
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: greater than 21 and no older than 50 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 24
Awards & highlights

Study Summary

This trial aims to find a better sleep solution to help reduce diabetes and obesity risk.

Who is the study for?
This trial is for African American adults aged 21-50 who are overweight with a BMI of 25 to 30 and usually sleep less than 7 hours at night. Participants should have the potential to sleep more if they had the time.Check my eligibility
What is being tested?
The study is testing two approaches to improve sleep health: one group will try sleeping longer (sleep extension), while another will focus on keeping a consistent sleep schedule (sleep regularity). The aim is to see if these methods can lower diabetes and obesity risk.See study design
What are the potential side effects?
Since this trial involves non-medical interventions related to sleep habits, side effects may include changes in mood or alertness, daytime drowsiness, or difficulty adapting to new sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 22 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glucose homeostasis after 24 days
Change in glucose homeostasis measured by Continuous Glucose Monitor (CGM)
Sleep Outcome- Regularity of sleep
+4 more
Secondary outcome measures
Changes from baseline through day 24 of novel Patient Reported Outcome instrument
Glucose Homeostasis- insulinogenic index
Glucose Homeostasis-First phase insulin response
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep RegularityExperimental Treatment1 Intervention
Participants in the sleep regularity group will have consistent bedtimes (within 30min).
Group II: Sleep ExtensionExperimental Treatment1 Intervention
Participants that are in the sleep extension group will have their time in bed extended by 2 hours. This can include going to bed earlier and/or waking up later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Extension
2017
N/A
~400

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,747 Total Patients Enrolled
15 Trials studying Obesity
1,986 Patients Enrolled for Obesity
Erin Hanlon, Ph.D.Principal InvestigatorUniversity of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project accepting new participants?

"Clinicialtrials.gov affirms that this clinical trial, which was originally published on the 1st of December 2023, is no longer recruiting participants. However, 383 other studies are currently looking for applicants."

Answered by AI

Does the current protocol for this trial allow individuals over 30 to participate?

"According to the study's required qualifications, prospective participants must be between 21 and 50 years of age."

Answered by AI

Who is the target population for this experiment?

"In order to be part of this study, individuals must have a body mass index that qualifies as obese and fall between the ages 21-50. The team is looking for 30 participants in total."

Answered by AI

What aims does this investigation seek to accomplish?

"This clinical trial evaluates participants over the course of 24 days, with a primary outcome measure being Sleep Efficiency. Secondary outcomes include observed changes in sleepiness, appetite, and mood as reported by patients through a novel instrument; Oral Disposition Index (DIo) estimated from oral glucose tolerance tests; Insulinogenic Index determined via plasma insulin and glucose levels collected during an OGTT."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sleep Extension or Regularity to Reduce Diabetes Risk in African American Adults
2024. "Sleep Extension or Regularity to Reduce Diabetes Risk in African American Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128265.
~20 spots leftby Apr 2025
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