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Behavioural Intervention

Sleep Extension for Sleep Deprivation

Phase 1 & 2
Recruiting
Led By Ivan Wu, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Phase 1: Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder), pregnant or less than 4 months postpartum, infant living in household less than 1 year old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to reduce health disparities related to obesity in African Americans by promoting healthy lifestyle behaviors. The trial will consist of two phases. Phase 1 involves conducting interviews to better understand sleep-related factors and

Who is the study for?
This trial is for African American adults who are not very active, sleep less than 6 hours a night, and are overweight or obese. It's designed to see if improving sleep can help with weight and health issues. People with certain medical conditions that could affect the study may not be able to join.
What is being tested?
The study tests whether a program aimed at helping participants sleep more (sleep extension intervention) can improve their health compared to regular check-ins without specific sleep advice (contact control intervention). The first phase gathers information, while the second phase tests the actual interventions.
What are the potential side effects?
Since this trial involves non-medical interventions like changing sleeping habits, side effects might include changes in mood or alertness due to altered sleep patterns. However, significant physical side effects are unlikely.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a chronic condition like COPD, heart rhythm problems, or stomach issues, am currently pregnant or recently had a baby, and have an infant at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the sleep intervention
Satisfaction with the sleep intervention

Awards & 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: sleep extension intervention armExperimental Treatment1 Intervention
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.
Group II: education contact control armActive Control1 Intervention
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

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Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,427 Previous Clinical Trials
1,620,483 Total Patients Enrolled
70 Trials studying Obesity
20,677 Patients Enrolled for Obesity
Ivan Wu, PhDPrincipal InvestigatorUniversity of Minnesota
~6 spots leftby Jan 2025
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