Sleep Clinical Trial - Cerebral MRI During Sleep

Status Completed

Clinical Trial Summary

Recent studies in animal models have suggested a critical role for cerebrospinal fluid and Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. This effect is modulated during sleep, suggesting a potentially important mechanism for sleep to maintain both acute homeostasis and long-term cerebral health.

The central goal of these studies is to develop a sensitive MRI biomarker of cerebral conformational changes during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation.

Clinical Trial Description

Recent studies in animal models have suggested a critical role for cerebrospinal fluid (CSF) / Interstitial fluid (ISF) flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. It remains unknown to what extent these phenomena exist in the human brain. A key challenge in this work is to make non-invasive and reproducible measurements of the cerebral microenvironment in humans. For these studies, the investigators have implemented a suite of MRI measurements to track physiological changes in the brain during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation. The long term goal of this work is to use MRI as an imaging biomarker to assess the cerebral response to normal versus disordered sleep in patients.

Our specific aims will address the following questions:

Aim 1: How sensitive are MRI metrics for determining changes in the brain during sleep?

Aim 2: How reproducible are MRI metrics during sleep and during sedation?

The investigators will recruit 12 normal adult subjects for this study (consecutive respondees to recruitment adverts). The investigators will make regional MRI measurements during onset, maintenance and waking from stage N2 sleep. From these the investigators will characterize which MRI metrics are most sensitive to changes in the cerebral environment, and how these vary for different cerebral regions.

Measurements will be repeated during ~90 minutes of natural sleep, and following oral sedation with 10 mg zaleplon (Sonata). ;

Study Design

Related Conditions & MeSH terms

Sleep

Clinical Trial Details

NCT number	NCT03304652
Study type	Observational
Source	University of California, San Diego
Contact
Status	Completed
Phase
Start date	October 1, 2017
Completion date	October 31, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Recruiting	`NCT06079853` - Nurse Suicide: Physiologic Sleep Health Promotion Trial	N/A
Completed	`NCT05017974` - Research on Improving Sleep During Pregnancy	N/A
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT04513743` - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ	N/A
Completed	`NCT03251274` - Bath Machine on Sleep Quality in Nursing Home	N/A
Completed	`NCT04102345` - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG	Early Phase 1
Completed	`NCT03725943` - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults	N/A
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Completed	`NCT04562181` - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index	N/A
Completed	`NCT05576844` - Ai Youmian (Love Better Sleep) for People Living With HIV	N/A
Completed	`NCT05102565` - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers	N/A
Completed	`NCT04688099` - Synovial Fluid Sleep Study
Recruiting	`NCT04171245` - Prescribing Laughter for Sleep and Wellbeing in UAE University Students	N/A
Completed	`NCT03758768` - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms	N/A
Completed	`NCT03163498` - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed	`NCT04093271` - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep	Phase 1
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04120363` - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.