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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

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 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

~490

0 / 5Eligibility criteria met