Exploring the Link Between Sleep and Brain Clearance

Not Applicable

• Conditions: Healthy Aging
• Interventions: Behavioral: Auditory Stimulation; Behavioral: Sham (no stimulation)

• Registration Number: NCT05539378
• Lead Sponsor: University Children's Hospital, Zurich

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.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Study Start: 2023-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Auditory Stimulation	Auditory Stimulation	Auditory Stimulation during sleep
No Auditory Stimulation	Sham (no stimulation)	Playing no tones during sleep but still recording brain activity

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 sample	2 weeks
Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample	2 weeks
Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)	2 weeks
Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample	2 weeks
Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy	2 weeks
Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire	2 weeks
Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)	2 weeks
Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire	2 weeks

Trial Locations

Locations (1)

Institute for Regenerative Medicine, University Hospital Zurich; 🇨🇭 Zurich, Switzerland