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Exploring the Link Between Sleep and Brain Clearance

Biomarkers of Brain Clearance During Sleep

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539378
Acronym
BBCDS
Enrollment
40
Registered
2022-09-14
Start date
2023-06-29
Completion date
2027-06-30
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging

Brief 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.

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.

Interventions

enhancement of sleep slow wave activity through acoustic stimulation

BEHAVIORALSham (no stimulation)

Playing no tones during sleep but still recording brain activity

Sponsors

University of Zurich
CollaboratorOTHER
University Children's Hospital, Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double (participant and outcomes assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI2 weeks
Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI2 weeks
Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI2 weeks
Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)2 weeks
Correlation between EEG slow wave activity (uV) and tau (pg/ml)2 weeks

Secondary

MeasureTime frame
Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)2 weeks
Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample2 weeks
Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire2 weeks
Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy2 weeks
Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)2 weeks
Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample2 weeks
Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire2 weeks
Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample2 weeks
Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)2 weeks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026