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Sleep Extension for Circadian Rhythm Disorder (STEAM Trial)
N/A
Recruiting
Led By Dean W Beebe, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 3 weeks for any given participant.
Awards & highlights
STEAM Trial Summary
This trial will study whether sleep promotion in adolescents leads to long-term health benefits by investigating how it affects calorie intake and foods high in glycemic load.
Who is the study for?
Healthy adolescents aged 14-18 can join this study on sleep and eating habits. It's not for those who are obese, take psychiatric drugs, have intellectual disabilities, insomnia, or other sleep disorders. Participants need a flexible schedule that allows early bedtimes and late wake-ups.Check my eligibility
What is being tested?
The study tests how extending sleep at different times (early night vs. late night) affects eating habits and long-term health in teens known as 'Morning Larks' and 'Night Owls'. The goal is to understand the impact of sleep changes on obesity prevention.See study design
What are the potential side effects?
Since the interventions involve changing sleep patterns rather than medication, side effects may include temporary changes in mood or alertness, difficulty adapting to new sleeping schedules, or increased daytime drowsiness.
STEAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 3 weeks for any given participant.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 3 weeks for any given participant.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic load consumed, as measured via 24-hr recall interviews
Overall Caloric Intake via 24-hr recall interviews using the United States Department of Agriculture (USDA) Multiple Pass Method
STEAM Trial Design
2Treatment groups
Experimental Treatment
Group I: Circadian-Misaligned Sleep ExtensionExperimental Treatment2 Interventions
A sleep extension period that does not conform to a given participant's circadian phase. In other words, this condition asks Morning Larks to extend their sleep by sleeping in later, or asks Night Owls to extend their sleep by going to bed earlier.
Group II: Circadian-Aligned Sleep ExtensionExperimental Treatment2 Interventions
A sleep extension period that roughly conforms to a given participant's circadian phase (i.e., fits the schedule of a Morning Lark vs. Night Owl).
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,392 Total Patients Enrolled
Rush UniversityOTHER
40 Previous Clinical Trials
383,814 Total Patients Enrolled
Dean W Beebe, PhDPrincipal InvestigatorCincinnati Children's
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that affects my sleep, weight, or eating habits.I have a neurological condition, have had seizures, or a serious head injury.You drink more than one cup of coffee or energy drink, or more than two caffeinated sodas every day.You cannot participate if you are obese because the study aims to help prevent obesity.I have symptoms of depression, bipolar disorder, or psychosis.I have sleep issues like insomnia or sleep apnea that could affect sleep study results.I am a healthy teenager between 14 and 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Circadian-Aligned Sleep Extension
- Group 2: Circadian-Misaligned Sleep Extension
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for qualifying to take part in this clinical research?
"This research initiative is set to include up 204 healthy individuals aged 14-18, regardless of race or gender."
Answered by AI
What is the current recruitment cap for this medical trial?
"Affirmative, the information on clinicaltrials.gov reveals that this research project is currently seeking participants. Originally posted on July 16th 2021 and refreshed as recently as July 8th 2022, 204 volunteers are required to be recruited from a single site."
Answered by AI
Does the research project include seniors in its cohort?
"This medical research is seeking subjects aged between 14 to 18 years old."
Answered by AI
Are interested participants being accepted into this experiment at the present time?
"Yes, indeed. The clinicaltrials.gov database indicates that this study is actively recruiting participants and was initially posted on July 16th 2021 before being updated lastly on July 8th 2022. 204 individuals from 1 site are required to finish the trial."
Answered by AI
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