Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness (NCT02311374) | Clinical Trial Compass
CompletedEarly Phase 1
Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness
United States40 participantsStarted 2015-07-28
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Between 18 and 60 years of age as determined by self-report.
✓. Ability to provide written informed consent as determined by physical examination and verbal communication.
Exclusion criteria
✕. Subjects with self-report of insomnia as determined by self-report and/or medical history;
✕. Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a C-PAP machine, sleeping during the day, using medication to fall asleep, sleeps less than 6 hours per night, night shift workers), subjects reporting snoring as determined by self-report using STOP-BANG questionnaire for undiagnosed OSA (3 or more yes answers will exclude) and/or medical history;
✕. Subjects with a history of restless leg syndrome as determined by self-report and/or medical history;
✕. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, tricyclic antidepressants, selective serotonin reuptake inhibitors \[SSRIs\], or serotonin norepinephrine reuptake inhibitors \[SNRIs\], benzodiazepines and barbiturates) as determined by self-report and/or medical history;
What they're measuring
1
To assess if there is an increase in the apparent diffusion coefficient (ADC) in the human brain during sleep when compared to the awake state and to determine if they vary across brain regions.
Timeframe: end of study
Trial details
NCT IDNCT02311374
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
✕. Current or past DSM-IV or DSM 5 diagnosis of a psychiatric disorder as determined by history and clinical exam including substance use disorder (except for nicotine/caffeine), alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM IV or DSM 5 will be excluded only if it required hospitalization (any length), or chronic medication management (more than 4 weeks), and that could impact brain function at the time of the study.
✕. Major medical problems that can impact brain function at the time of the scan (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam.
✕. Head trauma with loss of consciousness for more than 30 minutes as determined by self-report and/or medical history;
✕. Positive test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) on any day of study including upon check-in to NIH CC as determined by urine toxicology;