Establish a National Registry of REM Sleep Behavior Disorder

NCT ID: NCT03671798

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2022-04-30

Brief Summary

In this proposed study, the investigators aim to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

Detailed Description

REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Accumulating evidence suggests that RBD is implicated as an integral part of disease progress of α-synucleinopathy neurodegeneration, such as Parkinson's disease (PD) and dementia with Lewy bodies.Previous studies have identified a series of neurocognitive, autonomic, clinical and neurobiological markers for neurodegeneration in iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, the prevalence rate of RBD was relatively low and most of the RBD studies only have 100 or below cases. and there might be ethic differences in RBD which indicates that the findings from western countries might not be applicable to Chinese. In these regards, the investigators aimed to build up a large cohort of Rapid eye movement sleep behavior disorder (RBD) to study the etiology and risk factors of neurodegeneration.

Conditions

REM Sleep Behavior Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

REM sleep behavior disorder (RBD)

Diagnosis of RBD according to ICSD-3: 1) Sleep talking or complex movement during sleep. 2) Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM. 3) REM sleep without atonia (RWA) during PSG monitoring. 4) This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.

No interventions assigned to this group

Controls

Subjects with 1) No RBD symptoms and PSG characteristics. 2) No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology. 3) No narcolepsy or hypersomnia, ruled out by multiple sleep latency test. 4) No history of mental illnesses or use of antidepressants

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Case: According to the ICSD-3 for the diagnosis of RBD

1. Sleep talking or complex movement during sleep;

2. Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;

3. REM sleep without atonia (RWA) during PSG monitoring;

4. This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.

Control: Age and gender matched with consent

1. No RBD symptoms and PSG characteristics;

2. No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology;

3. No narcolepsy or hypersomnia, ruled out by multiple sleep latency test;

4. No history of mental illnesses or use of antidepressants.

Exclusion Criteria

1. Subjects who refused to join the cohort.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Zhang Jihui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihui Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Yun Kwok Wing, MBChB

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jihui Zhang, PhD

Role: CONTACT

jihui.zhang@cuhk.edu.hk

(852) 39197647

Facility Contacts

Jihui Zhang, PhD

Role: primary

Other Identifiers

2014.445

Identifier Type: -

Identifier Source: org_study_id