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OpenTrials
Completed

NCT Number: NCT03304652

Cerebral MRI During Sleep

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.

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Key information

Conditions

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego

San Diego, California, 92093-0677, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Adults

Exclusion criteria

  • age not in range 18-59
  • smoking / recreational drug use
  • pregnant women / breast feeding
  • contraindication to MRI
  • contraindications to Zaleplon
  • 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).
  • Current SSRI antidepressant medication
  • History of sleep disorder or currently taking sedative / stimulant medication

Treatment and study plan

Zaleplon

Drug

Sleep Aid; 10mg; Oral; Single Use

Other names: Sonata

Natural Sleep

Other

Natural Sleep without medication

Primary outcomes

  1. Cerebral MRI Changes

    Time frame: 90 Minutes of Sleep

    Change in MRI Signal from Awake Baseline

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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