NCT03576664 is a EARLY_PHASE1 clinical trial of Carvedilol 25mg in Sleep Deprivation, sponsored by Gitte Moos Knudsen.

Who is sponsoring NCT03576664?

NCT03576664 is sponsored by Gitte Moos Knudsen.

What drugs are being tested in NCT03576664?

Interventions in NCT03576664: Carvedilol 25mg, Placebo oral capsule.

What condition does NCT03576664 study?

NCT03576664 studies Sleep Deprivation, Sleep Wake Disorders, Sleep.

Is NCT03576664 still recruiting?

NCT03576664 is currently completed. Last updated 23 November 2022.

Last reviewed 2022-11-23 · How we verify

NCT03576664

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed EARLY_PHASE1 Last updated 23 November 2022

What this trial tests

EARLY_PHASE1 trial testing Carvedilol 25mg in Sleep Deprivation in 22 participants. Completed in 1 October 2019.

Timeline

28 August 2018

Primary endpoint
1 September 2019

1 October 2019

Quick facts

Lead sponsor	Gitte Moos Knudsen
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	22
Start date	28 August 2018
Primary completion	1 September 2019
Estimated completion	1 October 2019
Sites	1 location across Denmark

Drugs / interventions tested

Carvedilol 25mg — full drug profile →
Placebo oral capsule

Conditions studied

Sleep Deprivation — all drugs for Sleep Deprivation →
Sleep Wake Disorders — all drugs for Sleep Wake Disorders →
Sleep — all drugs for Sleep →

Sponsor

Gitte Moos Knudsen — full company profile →

Who can join

Adults 18 to 35, any sex, with Sleep Deprivation or Sleep Wake Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Sleep deprivation and sleep intensity exert distinct effects on cerebral vasomotion and brain pulsations driven by the respiratory and cardiac cycles.
Ulv Larsen SM, Holst SC, Olsen AS, Ozenne B, et al · · 2025 · cited 3× · PMID 41264592 · DOI 10.1371/journal.pbio.3003500

Verify or expand the search:

Other recruiting trials for Sleep Deprivation

Currently open trials in the same condition.

NCT07438912 — Mind After Midnight · NA · recruiting
NCT07329283 — Nighttime Synchrony of Your Nutrition and Circadian Health · NA · recruiting
NCT07294781 — Circadian Rhythms and Time Perception in Healthy Adults During Constant Wakefulness · NA · recruiting
NCT07085754 — Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes · NA · recruiting
NCT06492109 — The Peripheral Blood Multi-Omics Study on Sleep Loss · NA · recruiting

Other Gitte Moos Knudsen trials

Trials by the same sponsor.

NCT05450822 — Precision Medicine in the Treatment of Epilepsy · recruiting
NCT04280055 — Prophylactic Effects of Psilocybin on Chronic Cluster Headache · Phase 1, PHASE2 · terminated
NCT03289949 — The Neurobiological Effect of 5-HT2AR Modulation · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03576664 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gitte Moos Knudsen
Last refreshed: 23 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03576664.

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