Establish a National Registry of REM Sleep Behavior Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03671798|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
|Condition or disease|
|REM Sleep Behavior Disorder|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|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|
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.
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
- 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.
- 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.
- 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.
- 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
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
|Contact: Jihui Zhang, PhD||(852) email@example.com|
|Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Jihui Zhang, PhD|
|Principal Investigator:||Jihui Zhang, PhD||Chinese University of Hong Kong|
|Study Director:||Yun Kwok Wing, MBChB||Chinese University of Hong Kong|