Healthy AgingBBCDSNCT05539378
Exploring the Link Between Sleep and Brain Clearance
A study testing Auditory Stimulation in people with Healthy Aging, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess the link between sleep and the clearance of waste products from the brain. This will be assessed in a group of healthy older adults. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Auditory Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jun 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation in previous longitudinal cohort studies at the study site
- Ability to provide written and verbal informed consent
- Fluency in the German language
- Stable home situation that allows for reliable application of the intervention for the duration of the study
- Ability to apply the intervention for the duration of the study, either alone or with support from a co-habitant
- For women: Hormonal contraception, if menstrual cycle is still present or has been present within a year
- Good general health status, normal cognitive function
Who cannot join
- Failure or inability to give informed consent
- Inability to follow the procedures of the investigation
- For women: pregnancy or breastfeeding
- Presence of sleep disorders (e.g. sleep apnoea, narcolepsy, restless leg syndrome, insomnia, rapid eye movement (REM) sleep disorder)
- Shift-work or a home situation that requires several awakenings during the night (e.g. newborn)
- History of serious illness likely to interfere with study outcomes
Show all 10Show fewer
- Presence or history of a diagnosed neuropsychiatric illness
- Current diagnosis of uncontrolled or poorly controlled diabetes
- Current cancer of the brain or unstable cancer undergoing treatment
- Evidence of serious atherosclerotic cardiovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Institute for Regenerative Medicine, University Hospital Zurich
Zurich
About this study
Official title: Biomarkers of Brain Clearance During Sleep
The purpose of this study is to assess the link between sleep and the clearance of waste products from the brain. This will be assessed in a group of healthy older adults.
Read the detailed description
First, the investigators want to assess the relationship between sleep parameters and markers for brain clearance, assessed with MRI and blood samples. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.
- Conditions
- Healthy Aging
- Being tested
- Auditory Stimulation, Sham (no stimulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory StimulationBehavioural
enhancement of sleep slow wave activity through acoustic stimulation
Sham (no stimulation)Behavioural
Playing no tones during sleep but still recording brain activity
| Study group | Role | What they receive |
|---|---|---|
| Auditory Stimulation | Experimental | Auditory Stimulation during sleep Receives: Behavioral: Auditory Stimulation |
| No Auditory Stimulation | Sham comparator | Playing no tones during sleep but still recording brain activity Receives: Behavioral: Sham (no stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and tau (pg/ml)
Measured: 2 weeks
Secondary outcomes (9)
Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)
Measured: 2 weeks
Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start29 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
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 Healthy AgingStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Anton Gietl, Principal investigator, Institute for Regenerative Medicine, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539378
- Sponsor's protocol ID
- BBCDS
- Acronym
- BBCDS
- Status last verified
- Dec 2024
- First submitted
- 20 Jul 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meinhold L, Kaandorp MPT, Shang Z, Hauselmann M, Volk C, Treyer V, Huber R, Michels L, Gruber E, Studer ST, Buchmann A, Gietl A, Tuura RO. Exploring the link between intravoxel incoherent motion measured brain diffusivity during wakefulness and sleep macrostructure in the elderly. Neuroimage. 2026 Sep;338:122096. doi: 10.1016/j.neuroimage.2026.122096. Epub 2026 Jul 2.
PubMed 42392341
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Brain Clearance During Sleep
- ClinicalTrials.gov ID
- NCT05539378
- Acronym / sponsor ID
- BBCDS / BBCDS
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Sep 2022 (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 purpose of this study is to assess the link between sleep and the clearance of waste products from the brain. This will be assessed in a group of healthy older adults.
Detailed description
First, the investigators want to assess the relationship between sleep parameters and markers for brain clearance, assessed with MRI and blood samples. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory Stimulation | Experimental | Behavioral: Auditory StimulationAuditory Stimulation during sleep |
| No Auditory Stimulation | Sham comparator | Behavioral: Sham (no stimulation)Playing no tones during sleep but still recording brain activity |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participation in previous longitudinal cohort studies at the study site
- Ability to provide written and verbal informed consent
- Fluency in the German language
- Stable home situation that allows for reliable application of the intervention for the duration of the study
- Ability to apply the intervention for the duration of the study, either alone or with support from a co-habitant
Key exclusion criteria (10 listed)
- Failure or inability to give informed consent
- Inability to follow the procedures of the investigation
- For women: pregnancy or breastfeeding
- Presence of sleep disorders (e.g. sleep apnoea, narcolepsy, restless leg syndrome, insomnia, rapid eye movement (REM) sleep disorder)
- Shift-work or a home situation that requires several awakenings during the night (e.g. newborn)
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 |
|---|---|---|
| Auditory Stimulationenhancement of sleep slow wave activity through acoustic stimulation | Behavioural | Auditory Stimulation |
| Sham (no stimulation)Playing no tones during sleep but still recording brain activity | Behavioural | No Auditory Stimulation |
Primary outcome
Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and tau (pg/ml)
Time frame: 2 weeks
9 secondary outcomes
Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)
Time frame: 2 weeks
Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 42392341Meinhold L, Kaandorp MPT, Shang Z, Hauselmann M, Volk C, Treyer V, Huber R, Michels L, Gruber E, Studer ST, Buchmann A, Gietl A, Tuura RO. Exploring the link between intravoxel incoherent motion measured brain diffusivity during wakefulness and sleep macrostructure in the elderly. Neuroimage. 2026 Sep;338:122096. doi: 10.1016/j.neuroimage.2026.122096. Epub 2026 Jul 2.
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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.
Anton Gietl principal investigator
Institute for Regenerative Medicine, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Stimulation in people with Healthy Aging, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 7 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 9 Dec 2024. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI (time frame: 2 weeks). The study lists 5 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 NCT05539378, 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 9 Dec 2024.