REM Sleep Behavior Disorder Clinical Trial
Official title:
A 7-year Prospective Study of Idiopathic REM Sleep Behavior Disorder Cohort in Chinese Population: Determining the Optimal Characteristics of Biomarkers to Predict Neurodegenerative Diseases
NCT number | NCT04048603 |
Other study ID # | 2018.641 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2019 |
Est. completion date | October 1, 2022 |
This study is a prospective study with a mean of 7-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 patients with idiopathic REM Sleep Behavior Disorder (iRBD) and healthy controls.
Status | Recruiting |
Enrollment | 182 |
Est. completion date | October 1, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: for iRBD at baseline: 1. Fulfilling the diagnostic criteria for iRBD. As patients with iRBD were recruited during a long period, the diagnosis of RBD was based on ICSD and ICSD-2 (before 2014), and ICSD-3 (2014 and thereafter) criteria. The diagnosis for all patients were confirmed by video-PSG. In summary, patient diagnosed with RBD should present excessive EMG activity during REM sleep on video-PSG assessment and report a history of repeated dream enactment behaviors; 2. Having neurocognitive test and neurological examination since 2008; 3. Free of neurodegenerative diseases at the last visit. for controls without iRBD at baseline: 1. Age- and sex- matched with patients with iRBD; 2. Free of narcolepsy and other neurological diseases; 3. Without any RBD features as confirmed by both clinical history and video-PSG; 4. Without neurodegenerative diseases; 5. Having neurocognitive test and neurological examination at baseline. Exclusion Criteria: 1. Patients with narcolepsy; 2. Patients with known neurodegenerative diseases; 3. Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.); 4. Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD. |
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 | The overall conversion rate of iRBD to neurodegenerative diseases | The overall conversion rate of iRBD to neurodegenerative diseases. The diagnoses of neurodegenerative diseases will be ascertained by neurologists according to the standard diagnostic criteria. | Changes from baseline to 7 year follow up | |
Secondary | Changes of the likelihood ratio of probability of prodromal Parkinson's disease in each individual | The dynamic changes of the likelihood ratio of probability of prodromal Parkinson's disease in the patients with iRBD and healthy controls will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease. | Baseline and 7 year | |
Secondary | Conversion rate of iRBD to neurodegenerative diseases in patients with high and low likelihood ratio of probability of prodromal Parkinson's disease in each individual | Conversion rate of iRBD to neurodegenerative diseases in patients with high and low likelihood ratio of probability at baseline, the level of likelihood ratio was defined based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease. | Changes from baseline to 7 year follow up |
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