NCT03576664|CompletedEarly Phase 1
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Sponsor study identifier
Secondary identifiers
OTHER · Ethical Committee
interventional
22
1 country
1
Study Start
August 28, 2018
Actual (reported)Primary Completion
September 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2018
Actual (reported)July 3, 2018
Actual (reported)August 28, 2018
Actual (reported)September 1, 2019
Actual (reported)October 1, 2019
Actual (reported)Measure the change in functional Magnetic Resonance Imaging (fMRI)-detected glymphatic flow in wakefulness and sleep at baseline
Baseline compared to baseline - within same 1 day
Measure and compare functional Magnetic Resonance Imaging (fMRI)-detected glymphatic flow in baseline sleep and in sleep-deprived sleep
Baseline to follow-up 5±3 days
Measure and compare fMRI-detected glymphatic flow in placebo and carvedilol condition
Placebo compared to treatment 5±3 days apart.
Carvedilol (25 mg) followed by Placebo oral capsule is administered in a crossover manner.
Placebo oral capsule followed by Carvedilol (25 mg) is administered in a crossover manner.
Cross-over, randomized, placebo-controlled study.
Cross-over, randomized, placebo-controlled study.
Neurobiology Research Unit, Rigshospitalet
Copenhagen, 2100, Denmark
Ulv Larsen SM, Holst SC, Olsen AS, Ozenne B, Zilstorff DB, Brendstrup-Brix K, Weikop P, Pleinert S, Kiviniemi V, Jennum PJ, Nedergaard M, Knudsen GM. Sleep deprivation and sleep intensity exert distinct effects on cerebral vasomotion and brain pulsations driven by the respiratory and cardiac cycles. PLoS Biol. 2025 Nov 20;23(11):e3003500. doi: 10.1371/journal.pbio.3003500. eCollection 2025 Nov.
Sebastian C Sebastian, PhD
Neurobiology Research Unit, Rigshospitalet
22 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2018
First Posted
July 3, 2018
Study Start
August 28, 2018
Correlate fMRI-detected glymphatic flow with simultaneous detected EEG sleep slow wave activity
Nocturnal sleep compared to sleep during Magnetic Resonance scans within same 1 day.
Measure EEG slow wave activity during Magnetic Resonance imaging and compare Carvedilol with placebo to see how sleep is affected by the treatment
Placebo compared to treatment 5±3 days apart.
Measure if fMRI-detected glymphatic flow correlates with subjective sleepiness ratings
Measurements collected within the same 1 day
Measure fMRI-detected glymphatic flow and whether it correlates with cognitive performance before and after MR imaging
Measurements collected within the same 1 day
Measure fMRI-detected glymphatic flow and whether correlates with changes in cognitive performance from before to after MR imaging
Measurements collected within the same 1 day
Measure whether Carvedilol improves sleepiness after the MR scan compared to placebo
Measurements collected within the same 1 day
Measure whether Carvedilol improves cognitive performance (measurement: psychomotor vigilance test) after the MR scan compared to placebo
Measurements collected within the same 1 day
Measure whether fMRI-detected glymphatic flow is spatially correlated with simultaneous EEG NREM slow wave activity
Measurements collected within the same 1 day
Measure whether fMRI-detected glymphatic flow correlates with simultaneous NREM EEG activity
Measurements collected within the same 1 day
Measure whether fMRI-detected glymphatic flow is positively correlated with sleep driven structural changes in T2 and diffusion weighted (DWI) images
Measurements collected within the same 1 day
Measure whether Carvedilol modulates nocturnal recovery sleep (measurement: EEG slow wave activity) after sleep deprivation
Baseline to follow-up 5±3 days
Measure whether the psychomotor vigilance test is modulated by carvedilol
Placebo compared to treatment 5±3 days apart.
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)Last Updated
November 23, 2022
Record last verified: 2022-11
Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage). Data will be available for neuroscience research community contingent on approval by scientific board.
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Source: ClinicalTrials.gov.
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