Establish a National Registry of REM Sleep Behavior Disorder

• Conditions: REM Sleep Behavior Disorder

• Registration Number: NCT03671798
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	1 hour	Risk factors for neurodegenerative diseases were investigated in rapid eye movement sleep behavior disorder by questionnaires, including general information, life history, occupational history and family history.
Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder.	Baseline and biennial follow-up, up to 20 years	The percentage of REM-related EMG activity (REMREEA) is the most reliable and valid marker in differentiating patients with RBD from normal controls. Both REMREEA and significant motor activity were recorded by video-polysomnography in rapid eye movement sleep behavior disorder.
Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	Baseline and biennial follow-up, up to 20 years	Based on the large cohort of RBD, the investigators aim to study the etiology and the progression of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder by clinical assessment, including MoCA, olfactory dysfunction, color vision deficit and so on.
Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	Baseline and biennial follow-up, up to 20 years	Autonomic dysfunctions are also biomarkers for neurodegenerative diseases, the investigators aim to observe the changes of autonomic dysfunctions, including constipation, orthostatic hypotension and so on.

Trial Locations

Locations (1)

Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong