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Establish a National Registry of REM Sleep Behavior Disorder

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ClinicalTrials.gov Identifier: NCT03671798
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Zhang Jihui, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder
Study Start Date : October 2014
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

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



Primary Outcome Measures :
  1. Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder. [ Time Frame: 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.

  2. Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder. [ Time Frame: 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.

  3. Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder. [ Time Frame: 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.

  4. Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
TFT, Vitamin B12, Folate, CBC, Fasting Glucose, LFT, RFT, CRP, Fasting lipid, Iron profile, Phosphate, Calcium, Neurosteroid, Genetic analysis


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671798


Contacts
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Contact: Jihui Zhang, PhD (852) 39197647 jihui.zhang@cuhk.edu.hk

Locations
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Hong Kong
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Jihui Zhang, PhD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Jihui Zhang, PhD Chinese University of Hong Kong
Study Director: Yun Kwok Wing, MBChB Chinese University of Hong Kong

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Responsible Party: Dr. Zhang Jihui, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03671798     History of Changes
Other Study ID Numbers: 2014.445
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database

Additional relevant MeSH terms:
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Disease
Mental Disorders
REM Sleep Behavior Disorder
Pathologic Processes
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases