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

Withdrawn

• Conditions: Sleep Deprivation; Alzheimer Disease; Blood Brain Barrier Defect; Sleep Apnea

• Registration Number: NCT04096261
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-12
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of blood-brain dysfunction using CSF	1 day	Platelet-derived growth factor receptor-β in CSF
Sleep quality measurement	2 day	Polysomnography
Marker of blood-brain dysfunction using MRI	1 day	Dynamic T1 contrast enhanced sequence using Gadovist

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany