Clinical trial NCT05539378: Exploring the Link Between Sleep and Brain Clearance
Official title: Biomarkers of Brain Clearance During Sleep
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Aging
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2022-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and tau (pg/ml)
timeFrame: 2 weeks
Secondary outcomes:
measure: Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)
timeFrame: 2 weeks
measure: Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute for Regenerative Medicine, University Hospital Zurich
Study officials:
affiliation: Institute for Regenerative Medicine, University of Zurich
name: Anton Gietl
role: PRINCIPAL_INVESTIGATOR
References: