The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease

NCT ID: NCT04096261

Last Updated: 2022-07-27

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-12

Study Completion Date

2019-12-31

Brief Summary

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The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Detailed Description

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The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Sleep quality impairment is a known risk factor for memory impairment. There is increasing evidence of a link between measurable sleep parameters, in particular a reduction of slow waves of deep sleep in cognitive deficits. Also, breathing pauses during sleep are associated with increased daytime sleepiness and cognitive impairment. This observational study is intended to establish a possible link between subjective memory disturbances and altered sleep quality or respiratory breaks during sleep. In the run-up to this study, they performed a special MRI scan of the head and a lumbar puncture (removal of nerve water) in a different context. The aim of this imaging study and the new biomarker in brain water was to investigate the function of the blood-brain barrier that occurs in Alzheimer's disease. The results of the studies on the quality of sleep should be evaluated in the context of this study in connection with the findings of the MRI examination and lumbar puncture.

Conditions

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Blood Brain Barrier Defect Sleep Deprivation Sleep Apnea Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy controls

Healthy controls recruited through public advertisement.

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Siblings of people with Alzheimer's dementia

Siblings of people with Alzheimer's dementia recruited through public advertisement

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Subjective cognitive decline

Individuals who subjectively experience cognitive decline but do not show deficits in age-, sex- and education-normed neuropsychological test results. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Mild cognitive impairment

Individuals who show deficits in neuropsychological test procedures but who do not exhibit substantial problems in daily life. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Dementia due to Alzheimer's disease

Individuals diagnosed with dementia due to Alzheimer's disease by relying on anamnesis, neuropsychological test results, results of MRI and biomarkers found in the cerebrospinal fluid. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Interventions

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Diagnostic Test

Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

The eligibility criteria are defined by the study protocol from the observational study DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arda Can Cetindag

UNKNOWN

Sponsor Role collaborator

Lukas Preis

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Oliver Peters, MD

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BBB-Sleep

Identifier Type: -

Identifier Source: org_study_id

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