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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
Must not have
Hypertension: Participants with specific blood pressure criteria and history of beta blocker use
Pre-Diabetes/Diabetes: Participants with specific glucose level criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have high blood pressure and am taking beta blockers.
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I have pre-diabetes or diabetes based on my blood sugar levels.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Pressure
Changes in Alertness
Changes in Cognitive Performance
+23 more

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

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
994 Previous Clinical Trials
7,386,928 Total Patients Enrolled
Andrew McHill, PhDPrincipal InvestigatorOregon Health and Science University
1 Previous Clinical Trials
14 Total Patients Enrolled
~13 spots leftby Jun 2027
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