REM Sleep Behavior Disorder Clinical Trial
Official title:
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the First-degree Relatives of Patients With REM Sleep Behavior Disorder: a 5-year Prospective Study
NCT number | NCT03671772 |
Other study ID # | 24117018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 27, 2018 |
Est. completion date | April 27, 2020 |
Verified date | August 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (FDRs) of idiopathic REM Sleep Behavior Disorder (RBD) patients and healthy controls.
Status | Completed |
Enrollment | 170 |
Est. completion date | April 27, 2020 |
Est. primary completion date | April 27, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. Chinese aged 40 or above; 2. Being capable of giving informed consent for participation of the study; 3. Sex-matched. Exclusion Criteria: 1. Younger than 40 years old (as the supposed neurodegenerative process may not have occurred); 2. Not capable of giving informed consent for participation of the study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD. | Changes of the overall probability of prodromal Parkinson's disease will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease in the FDRs of patients with RBD. | Baseline and 5 years | |
Secondary | Changes of tonic EMG activity in the FDRs of patients with RBD. | Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD. | Baseline and 5 years | |
Secondary | Changes of physical activity level and circadian in the FDRs of patients with RBD. | Changes of physical activity level and circadian are recorded by one-week actigraphy in the FDRs of patients with RBD. | Baseline and 5 years | |
Secondary | New incidence of RBD and a-synucleinopathy in the FDRs of patients with RBD. | New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and a-synucleinopathies in the FDRs of patients with RBD. | Baseline and 5 years |
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