Clinical trial NCT03671798: Establish a National Registry of REM Sleep Behavior Disorder
Official title: Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: REM Sleep Behavior Disorder
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder.
timeFrame: 1 hour
measure: Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder.
timeFrame: Baseline and biennial follow-up, up to 20 years
measure: Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder.
timeFrame: Baseline and biennial follow-up, up to 20 years
measure: Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder.
timeFrame: Baseline and biennial follow-up, up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Jihui Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Yun Kwok Wing, MBChB
role: STUDY_DIRECTOR
References: