REM Sleep Behavior DisorderNCT04048603
Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder
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 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder, Neurodegeneration
- How many people
- 182 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2019to 1 Oct 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 50 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 cohort of RBD and control
Who may be able to join
- for iRBD at baseline:
- 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;
- Having neurocognitive test and neurological examination since 2008;
- Free of neurodegenerative diseases at the last visit.
- for controls without iRBD at baseline:
- Age- and sex- matched with patients with iRBD;
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- Free of narcolepsy and other neurological diseases;
- Without any RBD features as confirmed by both clinical history and video-PSG;
- Without neurodegenerative diseases;
- Having neurocognitive test and neurological examination at baseline.
Who cannot join
- Patients with narcolepsy;
- Patients with known neurodegenerative diseases;
- Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.);
- Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD.
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: 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
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.
Read the detailed description
REM sleep behavior disorder (RBD) is a parasomnia characterized by dream enactment behaviors and REM sleep without muscle atonia (excessive EMG activity) during REM sleep.Increasing studies revealed that iRBD eventually converts to α-synucleinopathy, such as Parkinson's disease (PD), dementia with Lewy Bodies (DLB), and multiple system atrophy (MSA). Recent studies reported that over 80% of patients with iRBD eventually developed neurodegeneration at a mean interval of 14 years after iRBD onset or diagnosed. Thus, iRBD is regarded as a precursor of α-synucleinopathies. In addition to iRBD, a large series of other non-motor symptoms also present before the emergence of typical motor symptoms of PD, including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment,neuroimaging of dopamine dysfunction, daytime sleepiness, and psychiatric disorders. In recent years, several longitudinal studies have found that patients with iRBD with a higher rate of these markers may have a faster progression of neurodegeneration. On the other hand, a variety of external risk factors of PD including environmental toxic exposure, lifestyle factors, and some medications have long been recognized, which affect numerous fundamental cellular processes by interaction with genetic predisposition.
However, several knowledge gaps still need further studies to uncover. First, few studies have explored the predictive value of dynamic change of biomarkers in prodromal stage of PD. Second, few previous prospective studies also employed a control group to compare the change of these prodromal markers between patients and healthy controls over time. Third, as some of previous studies employed a retrospective study design, potential recall bias may contaminate the results. Moreover, the sample sizes of most previous studies investigating biomarkers were relative small (n < 80) and follow-up durations in most study are relatively short, which may have limited the statistical power to detect the risk factors with mild to moderate effect size. Finally, as previous reported longitudinal studies of iRBD mainly focused on Caucasian or other ethnic groups, there is only limited data about neurodegenerative biomarkers in Chinese iRBD. In conclusion, prospective longitudinal studies with larger sample size, regular follow-up, and relative long follow-up duration are needed to better map the progression of neurodegeneration.
- Conditions
- REM Sleep Behavior Disorder, Neurodegeneration
- Keywords
- REM sleep behavior disorder, Neurodegeneration, α-synucleinopathy, Prodromal markers
- 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 |
|---|---|---|
| idiopathic REM sleep behavior disorder | Subjects with the diagnosis of idiopathic REM sleep behavior disorder | |
| Controls without iRBD | Healthy controls without the diagnosis of idiopathic REM sleep behavior disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline to 7 year follow up
Secondary outcomes (2)
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.
Measured: Baseline and 7 year
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.
Measured: Changes from baseline to 7 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 May 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Oct 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
- 182 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 KongYaping Liu, PhD, Study director, Chinese University of Hong KongSiu Ping Lam, MBChB, Study director, Chinese University of Hong KongShirley Xin Li, PhD, Study director, The University of Hong KongVincent Chung Tong Mok, MBChB, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048603
- Sponsor's protocol ID
- 2018.641
- Status last verified
- Aug 2021
- First submitted
- 22 Mar 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- 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
- ClinicalTrials.gov ID
- NCT04048603
- Acronym / sponsor ID
- 2018.641
- Conditions
- REM Sleep Behavior Disorder, Neurodegeneration
- Keywords
- REM sleep behavior disorder, Neurodegeneration, α-synucleinopathy, Prodromal markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 7 Aug 2019 (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 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.
Detailed description
REM sleep behavior disorder (RBD) is a parasomnia characterized by dream enactment behaviors and REM sleep without muscle atonia (excessive EMG activity) during REM sleep.Increasing studies revealed that iRBD eventually converts to α-synucleinopathy, such as Parkinson's disease (PD), dementia with Lewy Bodies (DLB), and multiple system atrophy (MSA). Recent studies reported that over 80% of patients with iRBD eventually developed neurodegeneration at a mean interval of 14 years after iRBD onset or diagnosed. Thus, iRBD is regarded as a precursor of α-synucleinopathies. In addition to iRBD, a large series of other non-motor symptoms also present before the emergence of typical motor symptoms of PD, including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment,neuroimaging of dopamine dysfunction, daytime sleepiness, and psychiatric disorders. In recent years, several longitudinal studies have found that patients with iRBD with a higher rate of these markers may have a faster progression of neurodegeneration. On the other hand, a variety of external risk factors of PD including environmental toxic exposure, lifestyle factors, and some medications have long been recognized, which affect numerous fundamental cellular processes by interaction with genetic predisposition.
However, several knowledge gaps still need further studies to uncover. First, few studies have explored the predictive value of dynamic change of biomarkers in prodromal stage of PD. Second, few previous prospective studies also employed a control group to compare the change of these prodromal markers between patients and healthy controls over time. Third, as some of previous studies employed a retrospective study design, potential recall bias may contaminate the results. Moreover, the sample sizes of most previous studies investigating biomarkers were relative small (n < 80) and follow-up durations in most study are relatively short, which may have limited the statistical power to detect the risk factors with mild to moderate effect size. Finally, as previous reported longitudinal studies of iRBD mainly focused on Caucasian or other ethnic groups, there is only limited data about neurodegenerative biomarkers in Chinese iRBD. In conclusion, prospective longitudinal studies with larger sample size, regular follow-up, and relative long follow-up duration are needed to better map the progression of neurodegeneration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic REM sleep behavior disorder | – | –Subjects with the diagnosis of idiopathic REM sleep behavior disorder |
| Controls without iRBD | – | –Healthy controls without the diagnosis of idiopathic REM sleep behavior disorder |
Who may qualify
- Ages
- 50 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 cohort of RBD and control
Key inclusion criteria (10 listed)
- 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;
- Having neurocognitive test and neurological examination since 2008;
- Free of neurodegenerative diseases at the last visit.
- Age- and sex- matched with patients with iRBD;
- Free of narcolepsy and other neurological diseases;
Key exclusion criteria (4 listed)
- Patients with narcolepsy;
- Patients with known neurodegenerative diseases;
- Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.);
- Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD.
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
The overall conversion rate of iRBD to neurodegenerative diseases
Time frame: Changes from baseline to 7 year follow up
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.
2 secondary outcomes
Changes of the likelihood ratio of probability of prodromal Parkinson's disease in each individual
Time frame: Baseline and 7 year
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
Time frame: Changes from baseline to 7 year follow up
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
Yaping Liu, PhD 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 10 inclusion and 4 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?
The overall conversion rate of iRBD to neurodegenerative diseases (time frame: Changes from baseline to 7 year follow up). 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.