REM Sleep Behavior DisorderNCT03671772
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD
An observational study of REM Sleep Behavior Disorder and Neurodegeneration, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder, Neurodegeneration
- How many people
- 170 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Sep 2018to 27 Apr 2020
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants in this proposed study will be recruited from our on-going family cohort of RBD
Who may be able to join
- Chinese aged 40 or above;
- Being capable of giving informed consent for participation of the study;
- Sex-matched.
Who cannot join
- Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
- Not capable of giving informed consent for participation of the study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong
About this study
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
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.
Read the detailed description
Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.
In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.
- Conditions
- REM Sleep Behavior Disorder, Neurodegeneration
- Keywords
- α-synucleinopathy, Neurodegeneration, Prodromal markers, REM sleep behavior disorder
- Medical subject headings
- REM Sleep Behavior Disorder, Nerve Degeneration
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 |
|---|---|---|
| FDRs of idiopathic RBD patients | First-degree relatives of idiopathic RBD patients | |
| FDRs of controls | First-degree relatives of controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 years
Secondary outcomes (3)
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.
New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and α-synucleinopathies in the FDRs of patients with RBD.
Measured: Baseline and 5 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 start27 Sep 2018
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
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
- 170 participants (actual)
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 KongVincent Chung Tong Mok, MBChB, Study director, Chinese University of Hong KongShirley Xin Li, PhD, Study director, Hong Kong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671772
- Sponsor's protocol ID
- 24117018
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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
- 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
- ClinicalTrials.gov ID
- NCT03671772
- Acronym / sponsor ID
- 24117018
- Conditions
- REM Sleep Behavior Disorder, Neurodegeneration
- Keywords
- α-synucleinopathy, Neurodegeneration, Prodromal markers, REM sleep behavior disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- 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.
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.
Detailed description
Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.
In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDRs of idiopathic RBD patients | – | –First-degree relatives of idiopathic RBD patients |
| FDRs of controls | – | –First-degree relatives of controls |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants in this proposed study will be recruited from our on-going family cohort of RBD
Key inclusion criteria (3 listed)
- Chinese aged 40 or above;
- Being capable of giving informed consent for participation of the study;
- Sex-matched.
Key exclusion criteria (2 listed)
- Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
- Not capable of giving informed consent for participation of the study.
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
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.
Time frame: Baseline and 5 years
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.
3 secondary outcomes
Changes of tonic EMG activity in the FDRs of patients with RBD.
Time frame: Baseline and 5 years
Changes of physical activity level and circadian in the FDRs of patients with RBD.
Time frame: Baseline and 5 years
New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.
Time frame: Baseline and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
Related trials for REM Sleep Behavior Disorder
RecruitingPhase 2
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
REM Sleep Behavior Disorder
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Active, not recruitingObservational study
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
REM Behavior Disorder, Parkinson Disease
Not yet recruitingObservational study
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD)
RecruitingObservational study
Neuroplasticity in RBD
REM Sleep Behavior Disorder
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
Vincent Chung Tong Mok, 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 and Neurodegeneration, 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 3 inclusion and 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD. (time frame: Baseline and 5 years). 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.