Effects of Sleep Deprivation and Adrenergic Inhibition on Glymphatic Flow in Humans

NCT03576664 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-11-23

No results posted yet for this study

Summary

The project is aimed at identifying how the adrenergic antagonist 'carvedilol' modulates the effects of sleep deprivation in healthy volunteers. The study is a double-blind, randomized, placebo-controlled, cross-over study. Investigators will include 20 healthy volunteers who will undergo three functional magnetic resonance (fMRI) imaging sessions, one at baseline, and two after sleep deprivation (one night without sleep). The two sleep-deprivation scans are performed in a randomized order where subjects receive placebo or carvedilol, in a within-subject, cross-over study design.

The following domains will be described: 1) fMRI imaging of cerebrospinal fluid (CSF) pulsations (glymphatic flow) in the human brain, performed by a combination of fMRI protocols that includes structural (T1, T2, diffusion weighted) and functional (multiband/fast imaging, spectroscopy) imaging. 2) fMRI imaging during wakefulness and sleep are determined by simultaneous electroencephalographic (EEG) recordings. 3) The effects of sleep deprivation on the fMRI derived glymphatic flow signal. 4) The effects of the adrenergic antagonist carvedilol on fMRI measurements and sleep intensity. 5) Quantification of cognitive performance before and after a nap in the MRI. Cognitive testing includes: assessments of visual attention, reaction time, paired-associative memory, working memory, emotional recognition and subjective ratings of sleepiness and mood.

Conditions

  • Sleep Deprivation
  • Sleep Wake Disorders
  • Sleep

Interventions

DRUG

Carvedilol 25mg

Cross-over, randomized, placebo-controlled study.

DRUG

Placebo oral capsule

Cross-over, randomized, placebo-controlled study.

Sponsors & Collaborators

  • Center for translational Neuromedicine, University of Copenhagen, Denmark

    collaborator UNKNOWN
  • Danish Center for Sleep Medicine

    collaborator OTHER
  • Gitte Moos Knudsen

    lead OTHER

Principal Investigators

  • Sebastian C Sebastian, PhD · Neurobiology Research Unit, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2019-09-01
Completion
2019-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576664 on ClinicalTrials.gov