REM Sleep Behavior Disorder Clinical Trial
Official title:
Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder
NCT number | NCT03671798 |
Other study ID # | 2014.445 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | April 2022 |
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
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 | Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder. | 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. | 1 hour | |
Primary | Changes of neurocognitive biomarkers for neurodegenerative diseases in rapid eye movement sleep behavior disorder. | 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. | Baseline and biennial follow-up, up to 20 years | |
Primary | Changes of autonomic dysfunctions for neurodegenerative diseases in rapid eye movement sleep behavior disorder. | 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. | Baseline and biennial follow-up, up to 20 years | |
Primary | Changes of REM-related EMG activity (REMREEA) and motor activity in rapid eye movement sleep behavior disorder. | 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. | Baseline and biennial follow-up, up to 20 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03671772 -
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD
|
||
Recruiting |
NCT05109364 -
Terazosin and Parkinson's Disease Extension Study
|
Phase 2 | |
Recruiting |
NCT03288909 -
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease
|
||
Completed |
NCT04006925 -
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
|
Phase 4 | |
Completed |
NCT03353207 -
Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration
|
||
Completed |
NCT02824341 -
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
|
N/A | |
Enrolling by invitation |
NCT01453127 -
DaTSCAN Imaging in Aging and Neurodegenerative Disease
|
Phase 4 | |
Terminated |
NCT02871427 -
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
|
Phase 2 | |
Completed |
NCT03595475 -
Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD
|
||
Recruiting |
NCT03660982 -
Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.
|
||
Completed |
NCT03255642 -
Efficacy and Safety of Melatonin and Clonazepam for IRBD
|
N/A | |
Recruiting |
NCT05904717 -
Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder
|
Phase 2 | |
Not yet recruiting |
NCT06140511 -
DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER
|
||
Recruiting |
NCT04386317 -
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
|
Phase 2 | |
Enrolling by invitation |
NCT05514106 -
MIBG in Aging and Neurologic Disorders
|
Phase 4 | |
Completed |
NCT03645226 -
Gut Microbiota Across Early Stages of Synucleinopathy: From High-risk Relatives, REM Sleep Behavior Disorder to Early Parkinson's Disease
|
||
Recruiting |
NCT05262543 -
PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study
|
||
Recruiting |
NCT04071899 -
French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
|
||
Recruiting |
NCT04048603 -
Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder
|
||
Completed |
NCT02708186 -
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
|
Phase 2 |