Protocol Details
CNS Correlates of Extended Sleep Restriction
This study is NOT currently recruiting participants.
Summary
Number | 000527-M |
Sponsoring Institute | National Institute of Mental Health (NIMH) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
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.
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05547880