REM Sleep Behavior DisorderNCT03671798
Establish a National Registry of REM Sleep Behavior Disorder
An observational study of REM Sleep Behavior Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder
- How many people
- 3,000 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2014to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be recruited from psychiatry outpatient clinics, Prince of Wales Hospital and 11 collaborated sites in mainland China.
Who may be able to join
- Case: According to the ICSD-3 for the diagnosis of RBD
- Sleep talking or complex movement during sleep;
- Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;
- REM sleep without atonia (RWA) during PSG monitoring;
- This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.
- Control: Age and gender matched with consent
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- No RBD symptoms and PSG characteristics;
- No neurological symptoms or diseases, MRI scan will be employed to exclude brain pathology;
- No narcolepsy or hypersomnia, ruled out by multiple sleep latency test;
- No history of mental illnesses or use of antidepressants.
Who cannot join
- 1. Subjects who refused to join the cohort.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong
Jihui Zhang, PhD
About this study
Official title: Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder
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.
Read the 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.
- Conditions
- REM Sleep Behavior Disorder
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
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.
Measured: Baseline and biennial follow-up, up to 20 years
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.
Measured: Baseline and biennial follow-up, up to 20 years
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.
Measured: Baseline and biennial follow-up, up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startOct 2014
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zhang Jihui, Chinese University of Hong Kong
- Investigators
- Jihui Zhang, PhD, Principal investigator, Chinese University of Hong KongYun Kwok Wing, MBChB, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671798
- Sponsor's protocol ID
- 2014.445
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Individual data sharing
- Undecided: Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a National Registry to Search for the Risk Factors, Etiology, and Neurodegenerative Progression of REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT03671798
- Acronym / sponsor ID
- 2014.445
- Conditions
- REM Sleep Behavior Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from psychiatry outpatient clinics, Prince of Wales Hospital and 11 collaborated sites in mainland China.
Key inclusion criteria (10 listed)
- Case: According to the ICSD-3 for the diagnosis of RBD
- Sleep talking or complex movement during sleep;
- Such movement was recorded by video PSG (AV-PSG) during REM sleep or according to history the movements were occurred during REM;
- REM sleep without atonia (RWA) during PSG monitoring;
- This abnormal phenomenon cannot be explained by other sleep disorder, psychiatric disease, drug or substance abuse.
Key exclusion criteria (1 listed)
- 1. Subjects who refused to join the cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Undecided. Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihui Zhang, PhD principal investigator
Chinese University of Hong Kong
Yun Kwok Wing, MBChB study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jihui Zhang, PhD ((852) 39197647, jihui.zhang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for neurodegenerative diseases in rapid eye movement sleep behavior disorder. (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.