Establish a National Registry of REM Sleep Behavior Disorder

REM Sleep Behavior Disorder Clinical Trial

Official title:

Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03671798
• Other study ID #: 2014.445
• Status: Recruiting
• Start date: October 2014
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: Chinese University of Hong Kong
• Contact: Jihui Zhang, PhD
• Phone: (852) 39197647
• Email: jihui.zhang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• REM Sleep Behavior Disorder

Locations

Country	Name	City	State
Hong Kong	Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	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.	1 hour
Primary	Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	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.	Baseline and biennial follow-up, up to 20 years
Primary	Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder.	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.	Baseline and biennial follow-up, up to 20 years
Primary	Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder.	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.	Baseline and biennial follow-up, up to 20 years