Sleep Extension for Sleep

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital Colorado, Aurora, COSleep+2 MoreSleep Extension - Behavioral
Eligibility
14 - 19
All Sexes
What conditions do you have?
Select

Study Summary

This trial plans to study how sleep may play a role in conditions like obesity and diabetes in teenagers.

Eligible Conditions
  • Sleep
  • Insulin Sensitivity
  • Eating Habits

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: 1 week after Baseline and 6 weeks after Baseline

Week 6
Change in Dietary Intake
2 weeks after Baseline
MTNR1B rs10830963 SNP
Week 7
Change in Insulin Sensitivity
Change in glycemic variability
Week 6
Change in Physical activity
Week 6
Change in Sleep Duration & Timing

Trial Safety

Trial Design

2 Treatment Groups

Typical Sleep
1 of 2
Sleep Extension
1 of 2

Active Control

Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: Sleep Extension · No Placebo Group · N/A

Sleep Extension
Behavioral
Experimental Group · 1 Intervention: Sleep Extension · Intervention Types: Behavioral
Typical SleepNoIntervention Group · 1 Intervention: Typical Sleep · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Extension
2017
N/A
~400

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week after baseline and 6 weeks after baseline

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,607 Previous Clinical Trials
1,931,378 Total Patients Enrolled
5 Trials studying Sleep
171 Patients Enrolled for Sleep
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,183 Previous Clinical Trials
4,088,897 Total Patients Enrolled
1 Trials studying Sleep
1,645 Patients Enrolled for Sleep
Stacey Simon, PhDPrincipal InvestigatorChildren's Hospital Colorado and University of Colorado Anschutz Medical Campus

Eligibility Criteria

Age 14 - 19 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a student in high school and your age is between 14 and 19 years old.
You do not engage in physical activity regularly (less than 3 hours per week).

Frequently Asked Questions

Is recruitment for this clinical experiment still available?

"Yes, the clinical trial is currently searching for qualified participants. According to information on clinicaltrials.gov, it was first posted in October 15th 2018 and recently updated on August 31st 2022. 75 patients are being recruited from a single medical site." - Anonymous Online Contributor

Unverified Answer

How many volunteers have enrolled in this medical research experiment?

"Affirmative. Clinicaltrials.gov displays information that indicates the ongoing recruitment of participants for this trial, which was initially posted on October 15th 2018 and last updated on August 31st 2022. 75 patients are being sought from one medical centre." - Anonymous Online Contributor

Unverified Answer

Does this research include participants who have surpassed their eightieth birthday?

"The study is open to participants aged between 14 and 19 years of age." - Anonymous Online Contributor

Unverified Answer

Which demographic is eligible to participate in this research?

"This experiment is accepting 75 teenagers, aged 14 to 19, who suffer from poor sleeping habits and a sedentary lifestyle (fewer than 3 hours of exercise per week). In addition, their BMI must be between the 5th-84th percentile for age and sex. Also, they have to have reached Tanner stage 4 or 5 based on sexual maturity assessment. Ultimately, participants are required to sleep fewer than 7 hours each night during school days." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.