NCT03304652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

October 3, 2017

Last Update Submit

March 12, 2019

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • Cerebral MRI Changes

    Change in MRI Signal from Awake Baseline

    90 Minutes of Sleep

Interventions

ZaleplonDRUG

Sleep Aid; 10mg; Oral; Single Use

Also known as: Sonata
Natural SleepOTHER

Natural Sleep without medication

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

12 normal adults for this study aged 18-59. Both male and female. Consecutive participant sampling

You may qualify if:

  • Healthy Adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

San Diego, California, 92093-0677, United States

Location

MeSH Terms

Interventions

zaleplon

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 9, 2017

Study Start

October 1, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)