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Behavioral Intervention

Sleep Restriction for Metabolic Health (SAM Trial)

N/A
Recruiting
Led By Andrew McHill, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Drug free
Between 18 and 40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

SAM Trial Summary

This trial is studying how sleep and circadian rhythm affect metabolism and glucose tolerance.

Who is the study for?
This trial is for drug-free adults aged 18-40 with no chronic diseases, a BMI between 18.5 and 25 kg/m2, waist circumference <94/80cm, non-smokers or minimal smoking history. Excludes those with immune, cardiovascular, respiratory disorders; metabolic syndrome; diabetes; sleep disorders; psychiatric conditions; current medication (except birth control); recent shift work or travel across time zones.Check my eligibility
What is being tested?
The study investigates how lack of sleep and circadian rhythm affect metabolism and glucose tolerance over a period of three weeks. Participants will undergo periods of sleep restriction in a controlled environment to determine the impact on their energy metabolism.See study design
What are the potential side effects?
Potential side effects from participating may include fatigue due to sleep deprivation, mood changes, increased stress levels, potential temporary alterations in eating habits and body weight as well as possible short-term changes in blood sugar levels.

SAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently taking any medications.
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I am between 18 and 40 years old.
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My cancer is currently in remission.

SAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Pressure
Changes in Alertness
Changes in Cognitive Performance
+23 more

SAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Restriction FirstExperimental Treatment1 Intervention
Equivalent to obtaining 5.5.h of sleep per 24h; n=10. Participants live on a 20h-day and will experience 15.33h wake episodes followed by sleep episodes of 4.67h long. Ad libitum food is provided during this time and participants will be fed ~130-150% of their daily caloric needs across three meals a day.
Group II: Controlled Condition FirstActive Control1 Intervention
Equivalent to obtaining 8h sleep per 24h; n=10. Participants live on a 20h-day and will experience 13.33h wake episodes followed by 6.67h sleep opportunities. Ad libitum food is provided during this time and participants will be fed ~130-150% of their daily caloric needs across three meals a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Restriction
2016
N/A
~470

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,892 Total Patients Enrolled
Andrew McHill, PhDPrincipal InvestigatorOregon Health and Science University
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

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

Does this research endeavor accommodate those younger than 65 years old?

"In accordance with the trial's recruitment requirements, only individuals aged between 18 and 40 can apply to participate."

Answered by AI

Am I able to participate in this research endeavor?

"For this medical trial, 20 individuals aged 18 to 40 with no history of drug abuse and a clean bill of health are necessary participants. Additionally, all applicants must meet the age criteria set by the study: between 18 and 40 years old."

Answered by AI

Are there any opportunities to participate in this trial at the moment?

"Affirmative. Per the clinicaltrials.gov website, this research project has been actively recruiting participants since December 1st 2023 and is looking for a total of 20 volunteer subjects from one medical facility. The details were last updated on September 18th 2023."

Answered by AI

How many participants are being included in this research project?

"Affirmative. According to clinicaltrials.gov, this trial is still recruiting participants from December 1st 2023 onwards and has most recently been updated on September 18th 2023. A single site will be taking in a total of 20 patients for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sleep and Metabolism
2023. "Sleep and Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05775627.
All > Weight Gain
~13 spots leftby Jun 2027
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