REM Sleep Behavior DisorderNCT03660982
Familial Aggregation and Biomarkers in REM Sleep Behaviour 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 cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between… 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
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2014to 30 Sep 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We established a case-control cohort of RBD with regular follow-ups and we have now accumulated over 280 RBD cases and age-sex matched controls. Proband of RBD and non-RBD controls will be recruited from this cohort. The control probands were initially recruited from the community and clinical samples (those with other sleep disorders such as obstructive sleep apnea syndrome) that did not have RBD as confirmed by clinical and vPSG assessments.
Who may be able to join
- Chinese aged 40 or above;
- Being capable of giving informed consent for participation of the study;
- Sex matched between relatives from probands and controls.
Who cannot join
- Aged 39 or below;
- Not capable of giving informed consent for participation of the study
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: Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder: a Case-control Family Study
In this cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.
Read the detailed description
REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Previous case-control studies and prospective studies have documented the progression of α-synucleinopathy neurodegeneration in relation to RBD and have identified some biomarkers of predicting neurodegeneration in patients with iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, these biomarkers might precede the onset of RBD, as a result, searching for biomarkers for the neurodegeneration before RBD onset is helpful to map the progression of neurodegeneration. In this regard, the investigators aim to study the familial aggregation of RBD and its core features, and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.
- 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 |
|---|---|---|
| FDRs of RBD cases | FDRs of RBD cases. The diagnosis of RBD is based on ICSD-II criteria, as confirmed by v-PSG and with the aid of REM sleep behaviour disorder questionnaire (RBDQ-HK). RBD cases which are secondary to narcolepsy, neurodegenerative diseases or other neurological diseases are excluded. | |
| FDRs of non-RBD controls | FDRs of non-RBD controls. Non-RBD control probands are free of narcolepsy, significant clinical RBD symptoms and other neurological diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence rate of probable RBD among first degree relatives of RBD probands
The prevalence rate of probable RBD based on the self-reported/proxy-reported RBD symptoms in RBDQ-HK among first degree relatives of RBD probands in comparison to that of first degree relatives of controls.
Measured: 15 minutes
The weighted prevalence rate of confirmed RBD among first degree relatives of RBD probands.
The weighted prevalence rate of first degree relatives meeting full ICSD-II2 diagnostic criteria for RBD confirmed by clinical history and vPSG.
Measured: one night (8 hours)
Secondary outcomes (3)
The percentage of REM-related EMG activity (REMREEA)
The percentage of REM-related EMG activity (REMREEA) is the most reliable and valid marker in differentiating patients with RBD from normal controls. Basically, the REMREEA include two components, namely phasic EMG activity and tonic EMG activity, respectively. The phasic EMG events were defined as any burst of EMG activity lasting 0.1 to 5 sec with amplitude > 4 times the background EMG activity and will be score on the basis of 3-second mini-epoch during REM sleep. Each 30-sec epoch during REM sleep was scored as tonic or atonic depending on whether tonic chin EMG activity was present for more or less than 50% of the epoch. The total EMG activity was presented as the percentage of REM related EMG activity (REMREEA) with the percentage of tonic EMG activity plus the percentage of phasic EMG activity.
Measured: one night (8 hours)
Significant motor activity
Significant motor activity were recorded by video-polysomnography. The motor analysis will be scored according to the previously established method. In view of the potential problem in inter-rater reliability in those mild motor activities, we will only include those complex activities and vocalizations in the analyses. It has been shown that there are large differences in the significant motor activities between patients with RBD and normal controls. In view of the relatively high night-to-night variability and low inter-rater reliability in scoring motor activity, it will be considered as secondary outcome.
Measured: one night (8 hours)
Other biomarkers of RBD in the first degree relatives of RBD patients.
Previous studies have also confirmed that RBD patients present with autonomic dysfunction, olfactory dysfunction, color vision deficit, neurocognitive function, and a higher rate of psychiatric disorders, these markers will also be considered as secondary biomarkers and will be compared in the first degree relatives of between patients and controls.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Oct 2014
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 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
- Cross-sectional
- Enrolment
- 400 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 KongSiuping LAM, Study director, Chinese University of Hong KongVicent Chung-tong MOK, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660982
- Sponsor's protocol ID
- 12131501
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Individual data sharing
- Undecided: In this stage, we didn't decide which information of IPD will share with other researchers.
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
- Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder: a Case-control Family Study
- ClinicalTrials.gov ID
- NCT03660982
- Acronym / sponsor ID
- 12131501
- Conditions
- REM Sleep Behavior Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2014
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 7 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 cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.
Detailed description
REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Previous case-control studies and prospective studies have documented the progression of α-synucleinopathy neurodegeneration in relation to RBD and have identified some biomarkers of predicting neurodegeneration in patients with iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, these biomarkers might precede the onset of RBD, as a result, searching for biomarkers for the neurodegeneration before RBD onset is helpful to map the progression of neurodegeneration. In this regard, the investigators aim to study the familial aggregation of RBD and its core features, and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDRs of RBD cases | – | –FDRs of RBD cases. The diagnosis of RBD is based on ICSD-II criteria, as confirmed by v-PSG and with the aid of REM sleep behaviour disorder questionnaire (RBDQ-HK). RBD cases which are secondary to narcolepsy, neurodegenerative diseases or other neurological diseases are excluded. |
| FDRs of non-RBD controls | – | –FDRs of non-RBD controls. Non-RBD control probands are free of narcolepsy, significant clinical RBD symptoms and other neurological diseases. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We established a case-control cohort of RBD with regular follow-ups and we have now accumulated over 280 RBD cases and age-sex matched controls. Proband of RBD and non-RBD controls will be recruited from this cohort. The control probands were initially recruited from the community and clinical samples (those with other sleep disorders such as obstructive sleep apnea syndrome) that did not have RBD as confirmed by clinical and vPSG assessments.
Key inclusion criteria (3 listed)
- Chinese aged 40 or above;
- Being capable of giving informed consent for participation of the study;
- Sex matched between relatives from probands and controls.
Key exclusion criteria (2 listed)
- Aged 39 or below;
- 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
The prevalence rate of probable RBD among first degree relatives of RBD probands
Time frame: 15 minutes
The prevalence rate of probable RBD based on the self-reported/proxy-reported RBD symptoms in RBDQ-HK among first degree relatives of RBD probands in comparison to that of first degree relatives of controls.
The weighted prevalence rate of confirmed RBD among first degree relatives of RBD probands.
Time frame: one night (8 hours)
The weighted prevalence rate of first degree relatives meeting full ICSD-II2 diagnostic criteria for RBD confirmed by clinical history and vPSG.
3 secondary outcomes
The percentage of REM-related EMG activity (REMREEA)
Time frame: one night (8 hours)
Significant motor activity
Time frame: one night (8 hours)
Other biomarkers of RBD in the first degree relatives of RBD patients.
Time frame: 2 hours
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. In this stage, we didn't decide which information of IPD will share with other researchers.
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
Siuping LAM 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 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: 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 prevalence rate of probable RBD among first degree relatives of RBD probands (time frame: 15 minutes). The study lists 2 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.