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Enrolling by Invitation

NCT Number: NCT05539378

Exploring the Link Between Sleep and Brain Clearance

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.

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Regenerative Medicine, University Hospital Zurich

Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory Stimulation

Behavioral

enhancement of sleep slow wave activity through acoustic stimulation

Sham (no stimulation)

Behavioral

Playing no tones during sleep but still recording brain activity

Primary outcomes

  1. Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI

    Time frame: 2 weeks

  2. Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI

    Time frame: 2 weeks

  3. Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI

    Time frame: 2 weeks

  4. Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)

    Time frame: 2 weeks

  5. Correlation between EEG slow wave activity (uV) and tau (pg/ml)

    Time frame: 2 weeks

Secondary outcomes

  1. Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire

    Time frame: 2 weeks

  2. Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire

    Time frame: 2 weeks

  3. Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)

    Time frame: 2 weeks

  4. Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)

    Time frame: 2 weeks

  5. Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample

    Time frame: 2 weeks

  6. Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample

    Time frame: 2 weeks

  7. Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample

    Time frame: 2 weeks

  8. Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)

    Time frame: 2 weeks

  9. Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • University of Zurich

Registry information

Official study title

Biomarkers of Brain Clearance During Sleep

Acronym: BBCDS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 14, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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