Exploring the Link Between Sleep and Brain Clearance

NCT ID: NCT05539378

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-29

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Healthy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (participant and outcomes assessor)

Study Groups

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Auditory Stimulation

Auditory Stimulation during sleep

Group Type EXPERIMENTAL

Auditory Stimulation

Intervention Type BEHAVIORAL

enhancement of sleep slow wave activity through acoustic stimulation

No Auditory Stimulation

Playing no tones during sleep but still recording brain activity

Group Type SHAM_COMPARATOR

Sham (no stimulation)

Intervention Type BEHAVIORAL

Playing no tones during sleep but still recording brain activity

Interventions

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Auditory Stimulation

enhancement of sleep slow wave activity through acoustic stimulation

Intervention Type BEHAVIORAL

Sham (no stimulation)

Playing no tones during sleep but still recording brain activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anton Gietl

Role: PRINCIPAL_INVESTIGATOR

Institute for Regenerative Medicine, University of Zurich

Locations

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Institute for Regenerative Medicine, University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BBCDS

Identifier Type: -

Identifier Source: org_study_id