Exploring the Link Between Sleep and Brain Clearance

Healthy Aging Clinical Trial

— BBCDS  

Official title:

Biomarkers of Brain Clearance During Sleep

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05539378
• Other study ID #: BBCDS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: August 2026

Study information

• Verified date: May 2023
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

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

Locations

Country	Name	City	State
Switzerland	Institute for Regenerative Medicine, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between EEG slow wave activity (uV) and cerebrospinal fluid flow (ml/min) from phase contrast MRI		2 weeks
Primary	Correlation between EEG slow wave activity (uV) and diffusivity (mm2/s) from diffusion MRI		2 weeks
Primary	Correlation between EEG slow wave activity (uV) and perfusion (ml/min/100 ml) from arterial spin labelling MRI		2 weeks
Primary	Correlation between EEG slow wave activity (uV) and beta-amyloid (pg/ml)		2 weeks
Primary	Correlation between EEG slow wave activity (uV) and tau (pg/ml)		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and fatigue, assessed via the fatigue severity scale (FSS) questionnaire		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and sleepiness, assessed with the Epworth Sleepiness Scale questionnaire		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and memory function, assessed with the Hopkins Verbal Learning Test (memory score)		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and attention, assessed with the Trail Making Test (time to completion)		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and C-Reactive Protein (mg/L), assessed from a blood sample		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and TNF-alpha (pg/L), assessed from a blood sample		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and interleukins (pg/L), assessed from a blood sample		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and executive function (summary score, dimensionless)		2 weeks
Secondary	Correlation between EEG slow wave activity (uV) and neuro-metabolite levels (mmol) from magnetic resonance spectroscopy		2 weeks