Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.

NCT ID: NCT03660982

Last Updated: 2021-08-06

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

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-01

Study Completion Date

2022-09-30

Brief Summary

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In this cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

Detailed Description

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REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Previous case-control studies and prospective studies have documented the progression of α-synucleinopathy neurodegeneration in relation to RBD and have identified some biomarkers of predicting neurodegeneration in patients with iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, these biomarkers might precede the onset of RBD, as a result, searching for biomarkers for the neurodegeneration before RBD onset is helpful to map the progression of neurodegeneration. In this regard, the investigators aim to study the familial aggregation of RBD and its core features, and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

Conditions

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REM Sleep Behavior Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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FDRs of RBD cases

FDRs of RBD cases. The diagnosis of RBD is based on ICSD-II criteria, as confirmed by v-PSG and with the aid of REM sleep behaviour disorder questionnaire (RBDQ-HK). RBD cases which are secondary to narcolepsy, neurodegenerative diseases or other neurological diseases are excluded.

No interventions assigned to this group

FDRs of non-RBD controls

FDRs of non-RBD controls. Non-RBD control probands are free of narcolepsy, significant clinical RBD symptoms and other neurological diseases.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Chinese aged 40 or above;
2. Being capable of giving informed consent for participation of the study;
3. Sex matched between relatives from probands and controls.

Exclusion Criteria

1. Aged 39 or below;
2. Not capable of giving informed consent for participation of the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Zhang Jihui

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jihui Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Yun Kwok Wing, MBChB

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Siuping LAM

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Vicent Chung-tong MOK

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

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Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Jihui Zhang, PhD

Role: CONTACT

(852) 39197647

Facility Contacts

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Jihui Zhang, PhD

Role: primary

Other Identifiers

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12131501

Identifier Type: -

Identifier Source: org_study_id

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