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Enrolling by invitation NCT05539378

Exploring the Link Between Sleep and Brain Clearance

No phase Interventional Healthy Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auditory Stimulation, Sham (no stimulation).
Who it may be relevant to
Registry conditions: Healthy Aging. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarkers of Brain Clearance During Sleep

Overview

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

  • Behavioral Auditory Stimulation
    enhancement of sleep slow wave activity through acoustic stimulation
  • Behavioral Sham (no stimulation)
    Playing no tones during sleep but still recording brain activity

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Switzerland · 1 center
  • Institute for Regenerative Medicine, University Hospital Zurich — Zurich

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. PMID 42392341

Identifiers

NCT: NCT05539378 · BBCDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗