Exploring the Link Between Sleep and Brain Clearance (BBCDS)

University of Zurich (UZH)

Status: Invitation-only

Conditions: Healthy Aging

Treatments: Behavioral: Sham (no stimulation); Behavioral: Auditory Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05539378

BBCDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Auditory Stimulation

Experimental group

Description:

Auditory Stimulation during sleep

Treatment:

Behavioral: Auditory Stimulation

No Auditory Stimulation

Sham Comparator group

Description:

Playing no tones during sleep but still recording brain activity

Treatment:

Behavioral: Sham (no stimulation)