Exploring the Link Between Sleep and Brain Clearance

Официальное название

Biomarkers of Brain Clearance During Sleep

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI [Срок оценки: 2 weeks]
• Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI [Срок оценки: 2 weeks]
• Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI [Срок оценки: 2 weeks]
• Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml) [Срок оценки: 2 weeks]
• Correlation between EEG slow wave activity (uV) and tau (pg/ml) [Срок оценки: 2 weeks]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швейцария · 1 центр

• Institute for Regenerative Medicine, University Hospital Zurich — Zurich

Публикации

• 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

Идентификаторы

NCT: NCT05539378 · BBCDS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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