Establish a National Registry of REM Sleep Behavior Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: REM Sleep Behavior Disorder

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Jihui Zhang, PhD; Phone Number: (852) 39197647; Email: jihui.zhang@cuhk.edu.hk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from psychiatry outpatient clinics, Prince of Wales Hospital and 11 collaborated sites in mainland China.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Mental Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: 2014.445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database