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Protocol Details

CNS Correlates of Extended Sleep Restriction

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000527-M

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 39 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Neonates;
Fetuses;
Children

Keywords

PET Imaging

Recruitment Keyword(s)

None

Condition(s)

Healthy

Investigational Drug(s)

[11C]ER176
[11C]UCB-J

Investigational Device(s)

None

Intervention(s)

Drug: 11C-ER176
Drug: 11C-UCB-J

Supporting Site

National Institute of Mental Health

Background:

Not getting enough sleep is a common problem. Chronic sleep restriction has a negative effect on a person s health and performance. Researchers want to understand more about how sleep loss affects brain function.

Objective:

To look for changes in the physiology of the brain caused by restricting sleep.

Eligibility:

Healthy adults aged 18 to 39.

Design:

Participants will be screened and enrolled through the Walter Reed Army Institute of Research (WRAIR). Some procedures will be done at the NIH clinic. The study will last 8 weeks and will include 4 visits to the NIH for a total of 6 positron emission tomography (PET) scans.

Participants will be transported to NIH from WRAIR in a government vehicle. They will be returned to WRAIR on the same day of each visit. Each visit may last up to 8 hours.

For each PET scan, participants will be injected with a radioactive substance. A needle will be used to guide a thin plastic tube (catheter) into a vein in the arm. The catheter will remain in the vein during the scans.

Participants will lie on a bed that slides into the scanner, which is shaped like a doughnut. A strap or a plastic mask will prevent the participant s head from moving during the scan. Participants will lie quietly without sleeping. Their vital signs (pulse, breathing) will be recorded multiple times. They may be asked to perform tasks such as counting. Each scan will last up to two and a half hours.

Blood will be drawn through a catheter placed in the wrist or elbow during some scans.

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Eligibility

CRITERIA:

-Ages 18 to 39 (inclusive)

-Weigh at least 140 lbs

-A body mass index (BMI) below 30.

-Females must not be pregnant or nursing, and must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)

-No history of sleeping problems such as insomnia or sleep apnea.

-Test negative for alcohol, nicotine, illegal drugs, and not take certain medications.

-Must not excessively consume alcohol or caffeine.

-Active duty and Federal employees must be on leave during participation.

-No history of heart disease (high blood pressure), neurologic disorder (such as seizures of epilepsy), liver disease, kidney disease, or metabolic disorder or diabetes.

-No history of underlying acute or chronic pulmonary disease requiring daily inhaler use.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert B. Innis, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM B1D43J
10 CENTER DR
BETHESDA MD 20892
(301) 594-1368
robert.innis@nih.gov

Robert B. Innis, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM B1D43J
10 CENTER DR
BETHESDA MD 20892
(301) 594-1368
robert.innis@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05547880

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