Establish a National Registry of REM Sleep Behavior Disorder

NCT03671798 | Unknown

• 1 other identifier: 2014.445
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Case: According to the ICSD-3 for the diagnosis of RBD
• Sleep talking or complex movement during sleep;
• Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;
• REM sleep without atonia (RWA) during PSG monitoring;
• This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.
• Control: Age and gender matched with consent
• No RBD symptoms and PSG characteristics;
• No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology;
• No narcolepsy or hypersomnia, ruled out by multiple sleep latency test;
• No history of mental illnesses or use of antidepressants.

You may not qualify if:

• \. Subjects who refused to join the cohort.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

TFT, Vitamin B12, Folate, CBC, Fasting Glucose, LFT, RFT, CRP, Fasting lipid, Iron profile, Phosphate, Calcium, Neurosteroid, Genetic analysis

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jihui Zhang, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Yun Kwok Wing, MBChB

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Jihui Zhang, PhD

CONTACT

(852) 39197647; jihui.zhang@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2014
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

HK (1)