Sleep DeprivationEarly Phase 1NCT03576664
Effects of Sleep Deprivation and Adrenergic Inhibition on Glymphatic Flow in Humans
A Early Phase 1 study testing Carvedilol 25mg in people with Sleep Deprivation and Sleep Wake Disorders, run by Gitte Moos Knudsen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Wake Disorders, Sleep
- What is being tested?
- Carvedilol 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2018to 1 Oct 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer (male or female) between 18 and 35 years.
- Good sleeper with sleep efficiency above 80%.
Who cannot join
- Current or former primary psychiatric disorder in volunteer of first degree relatives (DSM IV Axis I or WHO ICD-10 diagnostic classification).
- Current or previous neurological disease, severe somatic disease, or the consumption of drugs likely to influence the test results.
- Claustrophobia or fear of being in an MR-scanner.
- Alcohol or drug abuse.
- Regular smoking or nicotine addiction
- Extreme morning or evening type, or extreme short or long sleeper.
Show all 22Show fewer
- Disordered sleep, regular shift-work or extreme tiredness (e.g. Epworth Sleepiness Scale (ESS) > 10).
- Crossing of multiple time zones within the last 6 months.
- Extreme use of stimulants such as caffeine.
- Not adhering to the prescribed sleep-wake schedule before study initiation.
- Left handedness.
- Obesity (BMI > 27.5).
- Non-fluent in Danish or pronounced visual or auditory impairments.
- Current or past learning disability.
- Large head size (>59 cm in circumference).
- Pregnancy
- Contraindications for MRI (pacemaker, metal implants, etc.).
- Allergy to the ingredients in the administered drug.
- Abnormal ECG (e.g. prolonged QT syndrome, etc.)
- Dizzy when changing from supine to upright position (e.g. postural orthostatic tachycardia syndrome).
- Mild hypotension (blood pressure below 100/70 mmHg)
- Hypertension (blood pressure above 140/90 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aims and background:
Sleep is a universal biological process. Lack of, or insufficient sleep, has been associated with a range of diseases including obesity, cardiovascular disease, reduced cognition, impaired learning, and increased risk of motor vehicle accidents. Sleep is also associated with neuromolecular alterations in the brain, including reduced firing of arousal maintaining epinephrine and norepinephrine neurons.
A novel molecular function of sleep known as the glymphatic system has recently been described in rodents. This system is specifically activated during non-rapid eye movement (NREM) sleep, and glymphatic flow appear strongly enhanced during sleep when compared to wakefulness. Moreover, it has been shown that adrenergic antagonists enhance glymphatic clearance and flow in rodents. This study aims at applying newly developed functional magnetic resonance imaging (fMRI) protocols to investigate the extent of the glymphatic system non-invasively in humans.
In order for us to quantify the change in glymphatic clearance between sleep and wakefulness, it is necessary to measure the glymphatic process in both vigilance states, requiring that volunteers nap in the MRI scanner. Moreover, to clarify causal relationships, this study will challenge the glymphatic system via adrenergic inhibition. To do so, the investigators will administer the adrenergic antagonist Carvedilol, which can cross the blood-brain barrier. The drug will be perorally administered before a nap in the MRI, in a double blind, placebo controlled manner. To assess sleep quality and function, cognitive testing will be performed before and after the nap in the MRI scanner. Moreover, to distinguish sleep and wakefulness, electroencephalographic (EEG) recordings will be performed during magnetic resonance (MR)-imaging. Because sleep is a strong homeostatic regulated process, sleep quality, duration and timing will be controlled by EEG monitoring, immediately prior to and during the study to ensure that data is intra- and inter-individually comparable.
Hypotheses:
Investigators hypothesis that the fMRI data collected awake and during a nap will be altered by the adrenergic treatment. Specifically, investigator propose the following hypotheses: 1. Sleep promotes cerebrospinal fluid pulsations (glymphatic flow) in the human brain, as measured with fMRI. 2. Challenging the sleep-homeostat by sleep deprivation promotes the fMRI glymphatic flow signal further. 3. The rate of glymphatic flow is expected to be proportional to simultaneously measured non-rapid eye movement EEG slow wave activity. 4: The adrenergic antagonist carvedilol will enhance glymphatic clearance and sleep intensity. 5. The fMRI determined glymphatic flow is associated with improved cognitive performance following sleep. 6. Enhanced glymphatic flow is correlated with enhanced cognitive performance, including: 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
- Being tested
- Carvedilol 25mg, Placebo oral capsule
- Keywords
- carvedilol, adrenergic antagonists, glymphatic system, volunteers, Molecular Mechanisms of Pharmacological
- Medical subject headings
- Sleep Deprivation, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol 25mgDrug
Also called Coreg
Cross-over, randomized, placebo-controlled study.
Placebo oral capsuleDrug
Cross-over, randomized, placebo-controlled study.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol first | Experimental | Carvedilol (25 mg) followed by Placebo oral capsule is administered in a crossover manner. Receives: Drug: Carvedilol 25mg; Drug: Placebo oral capsule |
| Placebo first | Experimental | Placebo oral capsule followed by Carvedilol (25 mg) is administered in a crossover manner. Receives: Drug: Carvedilol 25mg; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the change in functional Magnetic Resonance Imaging (fMRI)-detected glymphatic flow in wakefulness and sleep at baseline
Measured: 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
Measured: Baseline to follow-up 5±3 days
Measure and compare fMRI-detected glymphatic flow in placebo and carvedilol condition
Measured: Placebo compared to treatment 5±3 days apart.
Correlate fMRI-detected glymphatic flow with simultaneous detected EEG sleep slow wave activity
Measured: 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
Measured: Placebo compared to treatment 5±3 days apart.
Measure if fMRI-detected glymphatic flow correlates with subjective sleepiness ratings
Measured: Measurements collected within the same 1 day
Measure fMRI-detected glymphatic flow and whether it correlates with cognitive performance before and after MR imaging
Measured: 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
Measured: Measurements collected within the same 1 day
Measure whether Carvedilol improves sleepiness after the MR scan compared to placebo
Measured: Measurements collected within the same 1 day
Measure whether Carvedilol improves cognitive performance (measurement: psychomotor vigilance test) after the MR scan compared to placebo
Measured: Measurements collected within the same 1 day
Secondary outcomes (9)
Measure whether fMRI-detected glymphatic flow is spatially correlated with simultaneous EEG NREM slow wave activity
Measured: Measurements collected within the same 1 day
Measure whether fMRI-detected glymphatic flow correlates with simultaneous NREM EEG activity
Measured: 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
Measured: Measurements collected within the same 1 day
Measure whether Carvedilol modulates nocturnal recovery sleep (measurement: EEG slow wave activity) after sleep deprivation
Measured: Baseline to follow-up 5±3 days
Measure whether the psychomotor vigilance test is modulated by carvedilol
Measured: Placebo compared to treatment 5±3 days apart.
Measure whether the visual attention (measurement: Theory of Visual Attention task) is modulated by carvedilol
Measured: Placebo compared to treatment 5±3 days apart.
Measure whether the visual attention (measurement: Theory of Visual Attention task) is modulated by sleep-deprivation
Measured: Baseline to follow-up 5±3 days
Measure whether emotional memory performance (measurement: emotional word pair task) is modulated by carvedilol
Measured: Placebo compared to treatment 5±3 days apart.
Measure whether emotional memory performance (measurement: emotional word pair task) is modulated by sleep-deprivation
Measured: Baseline to follow-up 5±3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start28 Aug 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gitte Moos Knudsen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Danish Center for Sleep Medicine
- Responsible party
- Sponsor-investigator, Gitte Moos Knudsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Sebastian C Sebastian, PhD, Principal investigator, Neurobiology Research Unit, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576664
- Sponsor's protocol ID
- sleepgf
- Other IDs
- H-16045933
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41264592
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Deprivation and Adrenergic Inhibition on Glymphatic Flow in Humans
- ClinicalTrials.gov ID
- NCT03576664
- Acronym / sponsor ID
- sleepgf
- Conditions
- Sleep Deprivation, Sleep Wake Disorders, Sleep
- Keywords
- carvedilol, adrenergic antagonists, glymphatic system, volunteers, Molecular Mechanisms of Pharmacological
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gitte Moos KnudsenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Danish Center for Sleep Medicine
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims and background:
Sleep is a universal biological process. Lack of, or insufficient sleep, has been associated with a range of diseases including obesity, cardiovascular disease, reduced cognition, impaired learning, and increased risk of motor vehicle accidents. Sleep is also associated with neuromolecular alterations in the brain, including reduced firing of arousal maintaining epinephrine and norepinephrine neurons.
A novel molecular function of sleep known as the glymphatic system has recently been described in rodents. This system is specifically activated during non-rapid eye movement (NREM) sleep, and glymphatic flow appear strongly enhanced during sleep when compared to wakefulness. Moreover, it has been shown that adrenergic antagonists enhance glymphatic clearance and flow in rodents. This study aims at applying newly developed functional magnetic resonance imaging (fMRI) protocols to investigate the extent of the glymphatic system non-invasively in humans.
In order for us to quantify the change in glymphatic clearance between sleep and wakefulness, it is necessary to measure the glymphatic process in both vigilance states, requiring that volunteers nap in the MRI scanner. Moreover, to clarify causal relationships, this study will challenge the glymphatic system via adrenergic inhibition. To do so, the investigators will administer the adrenergic antagonist Carvedilol, which can cross the blood-brain barrier. The drug will be perorally administered before a nap in the MRI, in a double blind, placebo controlled manner. To assess sleep quality and function, cognitive testing will be performed before and after the nap in the MRI scanner. Moreover, to distinguish sleep and wakefulness, electroencephalographic (EEG) recordings will be performed during magnetic resonance (MR)-imaging. Because sleep is a strong homeostatic regulated process, sleep quality, duration and timing will be controlled by EEG monitoring, immediately prior to and during the study to ensure that data is intra- and inter-individually comparable.
Hypotheses:
Investigators hypothesis that the fMRI data collected awake and during a nap will be altered by the adrenergic treatment. Specifically, investigator propose the following hypotheses: 1. Sleep promotes cerebrospinal fluid pulsations (glymphatic flow) in the human brain, as measured with fMRI. 2. Challenging the sleep-homeostat by sleep deprivation promotes the fMRI glymphatic flow signal further. 3. The rate of glymphatic flow is expected to be proportional to simultaneously measured non-rapid eye movement EEG slow wave activity. 4: The adrenergic antagonist carvedilol will enhance glymphatic clearance and sleep intensity. 5. The fMRI determined glymphatic flow is associated with improved cognitive performance following sleep. 6. Enhanced glymphatic flow is correlated with enhanced cognitive performance, including: assessments of visual attention, reaction time, paired-associative memory, working memory, emotional recognition and subjective ratings of sleepiness and mood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, cross-over, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Carvedilol first | Experimental | Drug: Carvedilol 25mg, Drug: Placebo oral capsuleCarvedilol (25 mg) followed by Placebo oral capsule is administered in a crossover manner. |
| Placebo first | Experimental | Drug: Carvedilol 25mg, Drug: Placebo oral capsulePlacebo oral capsule followed by Carvedilol (25 mg) is administered in a crossover manner. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer (male or female) between 18 and 35 years.
- Good sleeper with sleep efficiency above 80%.
Key exclusion criteria (22 listed)
- Current or former primary psychiatric disorder in volunteer of first degree relatives (DSM IV Axis I or WHO ICD-10 diagnostic classification).
- Current or previous neurological disease, severe somatic disease, or the consumption of drugs likely to influence the test results.
- Claustrophobia or fear of being in an MR-scanner.
- Alcohol or drug abuse.
- Regular smoking or nicotine addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol 25mgAlso: CoregCross-over, randomized, placebo-controlled study. | Drug | Carvedilol first, Placebo first |
| Placebo oral capsuleCross-over, randomized, placebo-controlled study. | Drug | Carvedilol first, Placebo first |
Primary outcome
Measure the change in functional Magnetic Resonance Imaging (fMRI)-detected glymphatic flow in wakefulness and sleep at baseline
Time frame: 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
Time frame: Baseline to follow-up 5±3 days
Measure and compare fMRI-detected glymphatic flow in placebo and carvedilol condition
Time frame: Placebo compared to treatment 5±3 days apart.
Correlate fMRI-detected glymphatic flow with simultaneous detected EEG sleep slow wave activity
Time frame: 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
Time frame: Placebo compared to treatment 5±3 days apart.
Measure if fMRI-detected glymphatic flow correlates with subjective sleepiness ratings
Time frame: Measurements collected within the same 1 day
Measure fMRI-detected glymphatic flow and whether it correlates with cognitive performance before and after MR imaging
Time frame: 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
Time frame: Measurements collected within the same 1 day
Measure whether Carvedilol improves sleepiness after the MR scan compared to placebo
Time frame: Measurements collected within the same 1 day
Measure whether Carvedilol improves cognitive performance (measurement: psychomotor vigilance test) after the MR scan compared to placebo
Time frame: Measurements collected within the same 1 day
9 secondary outcomes
Measure whether fMRI-detected glymphatic flow is spatially correlated with simultaneous EEG NREM slow wave activity
Time frame: Measurements collected within the same 1 day
Measure whether fMRI-detected glymphatic flow correlates with simultaneous NREM EEG activity
Time frame: 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
Time frame: Measurements collected within the same 1 day
Measure whether Carvedilol modulates nocturnal recovery sleep (measurement: EEG slow wave activity) after sleep deprivation
Time frame: Baseline to follow-up 5±3 days
Measure whether the psychomotor vigilance test is modulated by carvedilol
Time frame: Placebo compared to treatment 5±3 days apart.
Measure whether the visual attention (measurement: Theory of Visual Attention task) is modulated by carvedilol
Time frame: Placebo compared to treatment 5±3 days apart.
Measure whether the visual attention (measurement: Theory of Visual Attention task) is modulated by sleep-deprivation
Time frame: Baseline to follow-up 5±3 days
Measure whether emotional memory performance (measurement: emotional word pair task) is modulated by carvedilol
Time frame: Placebo compared to treatment 5±3 days apart.
Measure whether emotional memory performance (measurement: emotional word pair task) is modulated by sleep-deprivation
Time frame: Baseline to follow-up 5±3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 41264592Ulv 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian C Sebastian, PhD principal investigator
Neurobiology Research Unit, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Carvedilol 25mg in people with Sleep Deprivation and Sleep Wake Disorders, run by Gitte Moos Knudsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the change in functional Magnetic Resonance Imaging (fMRI)-detected glymphatic flow in wakefulness and sleep at baseline (time frame: Baseline compared to baseline - within same 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.