Cerebral MRI During Sleep

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT03304652
Collaborator
(none)
11
1
13
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Detailed 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

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cerebral MRI During Sleep
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Oct 31, 2018
Actual Study Completion Date :
Oct 31, 2018

Outcome Measures

Primary Outcome Measures

  1. Cerebral MRI Changes [90 Minutes of Sleep]

    Change in MRI Signal from Awake Baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Healthy Adults
Exclusion Criteria:
  1. age not in range 18-59

  2. smoking / recreational drug use

  3. pregnant women / breast feeding

  4. contraindication to MRI

  5. contraindications to Zaleplon

  6. history of cardiovascular pulmonary or cerebral disease (hypertension (diastolic >90 mmHg, systolic > 150 mmHg), unstable cerebrovascular syndromes, prior history of cardiac arrhythmias, unstable angina, chronic obstructive pulmonary disease).

  7. Current SSRI antidepressant medication

  8. History of sleep disorder or currently taking sedative / stimulant medication

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC San Diego San Diego California United States 92093-0677

Sponsors and Collaborators

  • University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Dubowitz, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03304652
Other Study ID Numbers:
  • 170804
First Posted:
Oct 9, 2017
Last Update Posted:
Mar 14, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2019