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NCT02311374 · ClinicalTrials.gov registry record · Early Phase 1
Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness
A Early Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT02311374: Completed Early Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT02311374 is a Early Phase 1 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311374, a Early Phase 1 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: \- The glymphatic system helps keep harmful waste from building up in the brain. Researchers think it is more active in people during sleep than while awake. They want to study the glymphatic system using magnetic resonance imaging (MRI). Objective: \- To see if there are differences in the way waste is removed from the brain while a person is sleeping versus awake. Eligibility: \- Healthy people age 18-60. Design: * This study is in 2 parts. * For the technical part (discontinued), participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests. * Participants will have 2 MRI scans. Before the scans, they will have urine and breath alcohol tests, and complete a questionnaire. * For MRI, participants will lie on a table that slides in and out of a metal cylinder. A device will be placed over their head. They will lie still for up to 20 minutes at a time. They may be asked to stay awake or fall asleep for up to 2 hours at a time. * For the research part, participants will be screened with medical history and physical exam. They will have urine and breath alcohol tests. For 1 week they will wear a device that monitors their activity and sleep. * Participants will stay at NIH overnight. They will give a blood sample, have urine and breath alcohol tests, and complete a questionnaire. * Participants will take memory, concentration, and thinking tests. * Participants will have 3 MRI scans. An electroencephalography machine will record their brain activity. Electrodes will be placed on their scalp.
Primary Outcome
To assess if there are differences between brain regions.
Interventions
- OTHER Brain connectivity and physiology
- OTHER Brain Wave
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-07-28 |
| Est. Completion | 2018-05-11 |
| Phase | Early Phase 1 |
What the finished NCT02311374 record still lists
NCT02311374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Brain connectivity and physiology is the first listed.
NCT02311374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02311374 about?
NCT02311374 is a clinical study titled "Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness". Background: \- The glymphatic system helps keep harmful waste from building up in the brain. Researchers think it is more active in people during sleep than while awake. They want to study the glymphatic system using magnetic resonance imaging (MRI). Objective: \- To see if there are differences ...
What is the current status of trial NCT02311374?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2015-07-28. Estimated completion is 2018-05-11.
What interventions are being tested in trial NCT02311374?
The interventions under investigation include: Brain connectivity and physiology (OTHER), Brain Wave (OTHER).
Who is sponsoring clinical trial NCT02311374?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02311374's enrollment target sits among peer trials
40 629th of 2000 higher than 1,312 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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