REM Sleep Behavior DisorderNCT03595475
Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD
An observational study of REM Sleep Behavior Disorder, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
REM sleep behavior disorder (typical or 'idiopathic' RBD, iRBD) is a novel and distinct parasomnia characterized by recurrent dream enactment behaviours and polysomnographic features of loss of normal REM-sleep related muscle atonia, with a male predominance commonly occurring at the age of 60's. 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
- 408 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Oct 2017to 31 Mar 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: In this study, we will employ a combination of family history (proxy report for unavailable/inaccessible subjects) and study (face-to face interview, clinical and sleep study) method in determining the familial aggregation of pRBD. The flowchart of subject recruitments is presented in Figure 1. The study subjects are the FDRs of pRBD cases, psychiatric controls and healthy controls. As previous studies have suggested that depression is a significant risk factor of development of Parkinson's Disease, we will include two control groups. First, those FDRs of patients with psychiatric disorders in addition to the FDRs of healthy controls (free of depression and RBD), in consideration of the potential associations of proband's psychiatric disorders with prodromal markers of Parkinson's Disease in the FDRs.
Who may be able to join
- Age- and sex- matched with pRBD proband;
- Without lifetime psychiatric disorder according to Structural Clinical Interview for DSM-IV Disorders (SCID);
- Free of narcolepsy and other neurological diseases;
- Absence of any RBD features as based on RBDQ-HK and v-PSG;
- free of neurodegenerative diseases.
Who cannot join
- Not Chinese or aged under 40 years old;
- Refuse to participate in this study;
- without a biological relationship with proband.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Chinese University of Hong Kong
Hong Kong
Shatin Hospital
Shatin
About this study
Official title: Prodromal Markers of α-synucleinopathy Neurodegeneration in the First-degree Relatives of Patients With Psychiatric Disorders Comorbid With REM Sleep Behavior Disorder
REM sleep behavior disorder (typical or 'idiopathic' RBD, iRBD) is a novel and distinct parasomnia characterized by recurrent dream enactment behaviours and polysomnographic features of loss of normal REM-sleep related muscle atonia, with a male predominance commonly occurring at the age of 60's. A majority of the patients with iRBD will eventually develop α-synucleinopathy (e.g., Parkinson's disease). On the other hand, growing evidence reveals a specific group of psychiatric patients demonstrating comparable clinical RBD features (pRBD) (e.g., abnormal REM-related electromyographic (EMG) activities) as found in typical iRBD, but with less male predominance occurring at the age of mid 40's to early 50's. Although recent findings from both cross-sectional and prospective studies have suggested that pRBD is likely to be a persistent parasomnia with close association with clinical and neuroimaging biomarkers related to neurodegeneration, the nosology of the development of RBD symptoms among patients with psychiatric disorders, notably major depressive disorder, remains unclear as to whether they are simply antidepressants related, or represent a part of the early phase of α-synucleinopathy neurodegeneration. Family studies on iRBD have confirmed a significant familial aggregation of iRBD with a higher rate of RBD cases and presence of prodromal neurodegenerative biomarkers (e.g. tonic EMG activity during REM sleep, constipation, and motor function impairments) of α-synucleinopathy neurodegeneration among first-degree relatives (FDRs) of patients with iRBD. Thus, the investigators propose this family study to examine the following hypotheses: 1) FDRs of patients with pRBD have a higher rate of RBD symptoms and its core features when compared to FDRs of controls with and without psychiatric disorders; 2) FDRs of pRBD are more likely to exhibit the features associated with prodromal markers of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders; 3) FDRs of patients with pRBD have a higher rate of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders. A total of 176 FDRs from each group (e.g., pRBD cases, psychiatric controls, and healthy controls) will be recruited to undergo a face-to-face clinical interview and a series of assessments on prodromal markers of Parkinson's diseases (as according to the International Parkinson and Movement Disorder Society research criteria) respectively.
All FDRs with possible RBD and a subset of FDRs without possible RBD will be invited to undergo one-night video-polysomnographic assessment to confirm the clinical diagnosis of RBD and to assess the abnormal REM-related EMG muscle activities.
Read the detailed description
REM sleep behavior disorder (RBD) is a novel REM sleep parasomnia characterized by dream enacting behaviors and sleep-related injuries. Ample evidences have suggested that idiopathic RBD (iRBD) is a precursor of α-synucleinopathy neurodegeneration (e.g. Parkinson's disease, PD) in which dopamine dysfunction is one of the core pathophysiologies. In recent decade, our group has identified a cohort of patients with psychiatric disorders (mainly major depressive disorder, MDD) comorbid with RBD (pRBD). While there was a postulation that RBD symptoms in this psychiatric population may simply be side effects of antidepressant medication (by enhancing REM-sleep related muscle activity), accumulating evidence from case-control and prospective cohort studies suggested that pRBD is only partially explained by antidepressant usage and is better considered as a variant of typical iRBD in terms of comparable clinical presentation with typical iRBD and its close association with neurodegenerative markers. Nonetheless, more evidence is needed to substantiate that pRBD is a distinct diagnostic entity rather than a symptom secondary to antidepressant use. In this study, the investigators will employ genetic epidemiology approach to: 1) determine the familial genetic contribution; 2) search for biomarkers and endophenotypes; and 3) validate the diagnostic entity of a disease.
This proposed study will enrich the limited scientific literature of the potential pathogenesis of pRBD and its relationship with α-synucleinopathy. In addition, the understanding of psychiatric disorders, notably MDD, is often limited by its heterogeneity. Our proposed study will, by determining the familial aggregation of pRBD, help us to identify certain subtype of the psychiatric populations who may likely harbour an underlying neurodegenerative basis. By using a family study design, a number of important aspects with regard to the pathogenesis of pRBD will be answered. First, if first-degree relatives (FDRs) of patients with pRBD have a higher rate of possible RBD or clinical diagnosis of RBD (as confirmed by video-polysomnography) as well as the presence of neurodegenerative diseases when compared with FDRs of controls, it will substantiate the argument that pRBD is not merely a side effect of antidepressants but rather harbouring a familial and genetic predisposition to RBD and, ultimately α-synucleinopathy neurodegeneration. Second, the determination of biomarkers of neurodegeneration among unaffected FDRs of patients with pRBD will also help to identify high-risk individuals for clinical intervention and prevention. Third, the calculation of heritability will help to delineate to which extent the additive genetic contribution is responsible for the variance of pRBD phenotypes. Finally, the findings from this proposed study will be compared with our on-going family study of typical iRBD to determine the extent to which iRBD and pRBD are similar or different to each other in terms of genetic and familial associations.
In this proposed study, the investigators hypothesize that:
- FDRs of patients with pRBD have a higher rate of RBD symptoms and its core features compared with FDRs of controls;
- The unaffected FDRs of patients with pRBD are more likely to exhibit the features associated with prodromal markers of Parkinson's disease compared with FDRs of controls;
- FDRs of patients with pRBD have a higher rate of Parkinson's disease (and other α-synucleinopathy neurodegeneration) compared with FDRs of controls.
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- Prodromal markers, Psychiatric disorders, α-synucleinopathy, Family study
- Medical subject headings
- REM Sleep Behavior Disorder, Mental Disorders
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 |
|---|---|---|
| Psychiatric RBD cases | 1. Presence of REM sleep without atonia; 2. At least one of the followings is present: i). Dream enactment behaviors, SRIs, potentially injurious or disruptive behaviors by history; ii). Abnormal REM sleep behaviors documented during v-PSG monitoring; 3. Absence of electroencephalogram (EEG) epileptiform activity during REM sleep unless RBD can be clearly distinguished from any concurrent REM sleep related seizure disorder; 4. The sleep disturbance is not better explained by other sleep disorder (e.g., obstructive sleep apnea, medical or neurological disorder, mental disorder, medication use, or substance use disorder) | |
| Psychiatric control | 1. Age- and sex- matched with pRBD proband; 2. Concurrent psychiatric illnesses according to the Mini International Neuropsychiatric Interview( M.I.N.I); 3. Free of narcolepsy and other neurological diseases; 4. Absence of any RBD features as based on REM sleep behavior disorder questionnaire (RBDQ-HK) and v-PSG; 5) Free of neurodegenerative diseases | |
| Healthy control | 1. Age- and sex- matched with pRBD proband; 2. Without lifetime psychiatric disorder according to Mini International Neuropsychiatric Interview( M.I.N.I); 3. Free of narcolepsy and other neurological diseases; 4. Absence of any RBD features as based on RBDQ-HK and v-PSG; 5. Free of neurodegenerative diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of possible REM Sleep Behavior Disorder
The prevalence of possible REM Sleep Behavior Disorder based on the self-reported/proxy-reported REM Sleep Behavior Disorder symptoms in REM Sleep Behavior Disorder Questionnaire-HK among First Degree Relatives,
Measured: 17 months
Secondary outcomes (3)
Percentage of REM-related EMG activity
The mean differences in the percentage of REM-related EMG activity among First Degree Relatives in different groups
Measured: 17 months
Weighted prevalence of Polysomnography confirmed REM Sleep Behavior Disorder
Prevalence of Polysomnography confirmed REM Sleep Behavior Disorder according to ICSD-3 criteria among First Degree Relatives in different groups
Measured: 17 months
Recurrence risk of Parkinson's disease
Risk of Parkinson's disease and other α-synucleinopathy neurodegeneration based on family history report and face-to-face interview among First Degree Relatives in different groups
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Oct 2017
- Primary completion30 Nov 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Wing Yun Kwok, Chinese University of Hong Kong
- Investigators
- Yun Kwok Wing, Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595475
- Sponsor's protocol ID
- RGC14172917
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2018
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In this stage, the investigators didn't decide which information of IPD will share with other researchers
Publications
Wang J, Lam SP, Huang B, Liu Y, Zhang J, Yu MWM, Tsang JCC, Zhou L, Chau SWH, Chan NY, Chan JWY, Schenck CH, Li SX, Mok VCT, Ma KKY, Chan AYY, Wing YK. Familial alpha-synucleinopathy spectrum features in patients with psychiatric REM sleep behaviour disorder. J Neurol Neurosurg Psychiatry. 2023 Nov;94(11):893-903. doi: 10.1136/jnnp-2022-330922. Epub 2023 Jun 30.
PubMed 37399287
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prodromal Markers of α-synucleinopathy Neurodegeneration in the First-degree Relatives of Patients With Psychiatric Disorders Comorbid With REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT03595475
- Acronym / sponsor ID
- RGC14172917
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- Prodromal markers, Psychiatric disorders, α-synucleinopathy, Family study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 23 Jul 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.
REM sleep behavior disorder (typical or 'idiopathic' RBD, iRBD) is a novel and distinct parasomnia characterized by recurrent dream enactment behaviours and polysomnographic features of loss of normal REM-sleep related muscle atonia, with a male predominance commonly occurring at the age of 60's. A majority of the patients with iRBD will eventually develop α-synucleinopathy (e.g., Parkinson's disease). On the other hand, growing evidence reveals a specific group of psychiatric patients demonstrating comparable clinical RBD features (pRBD) (e.g., abnormal REM-related electromyographic (EMG) activities) as found in typical iRBD, but with less male predominance occurring at the age of mid 40's to early 50's. Although recent findings from both cross-sectional and prospective studies have suggested that pRBD is likely to be a persistent parasomnia with close association with clinical and neuroimaging biomarkers related to neurodegeneration, the nosology of the development of RBD symptoms among patients with psychiatric disorders, notably major depressive disorder, remains unclear as to whether they are simply antidepressants related, or represent a part of the early phase of α-synucleinopathy neurodegeneration. Family studies on iRBD have confirmed a significant familial aggregation of iRBD with a higher rate of RBD cases and presence of prodromal neurodegenerative biomarkers (e.g. tonic EMG activity during REM sleep, constipation, and motor function impairments) of α-synucleinopathy neurodegeneration among first-degree relatives (FDRs) of patients with iRBD. Thus, the investigators propose this family study to examine the following hypotheses: 1) FDRs of patients with pRBD have a higher rate of RBD symptoms and its core features when compared to FDRs of controls with and without psychiatric disorders; 2) FDRs of pRBD are more likely to exhibit the features associated with prodromal markers of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders; 3) FDRs of patients with pRBD have a higher rate of α-synucleinopathy neurodegeneration when compared with FDRs of controls with and without psychiatric disorders. A total of 176 FDRs from each group (e.g., pRBD cases, psychiatric controls, and healthy controls) will be recruited to undergo a face-to-face clinical interview and a series of assessments on prodromal markers of Parkinson's diseases (as according to the International Parkinson and Movement Disorder Society research criteria) respectively.
All FDRs with possible RBD and a subset of FDRs without possible RBD will be invited to undergo one-night video-polysomnographic assessment to confirm the clinical diagnosis of RBD and to assess the abnormal REM-related EMG muscle activities.
Detailed description
REM sleep behavior disorder (RBD) is a novel REM sleep parasomnia characterized by dream enacting behaviors and sleep-related injuries. Ample evidences have suggested that idiopathic RBD (iRBD) is a precursor of α-synucleinopathy neurodegeneration (e.g. Parkinson's disease, PD) in which dopamine dysfunction is one of the core pathophysiologies. In recent decade, our group has identified a cohort of patients with psychiatric disorders (mainly major depressive disorder, MDD) comorbid with RBD (pRBD). While there was a postulation that RBD symptoms in this psychiatric population may simply be side effects of antidepressant medication (by enhancing REM-sleep related muscle activity), accumulating evidence from case-control and prospective cohort studies suggested that pRBD is only partially explained by antidepressant usage and is better considered as a variant of typical iRBD in terms of comparable clinical presentation with typical iRBD and its close association with neurodegenerative markers. Nonetheless, more evidence is needed to substantiate that pRBD is a distinct diagnostic entity rather than a symptom secondary to antidepressant use. In this study, the investigators will employ genetic epidemiology approach to: 1) determine the familial genetic contribution; 2) search for biomarkers and endophenotypes; and 3) validate the diagnostic entity of a disease.
This proposed study will enrich the limited scientific literature of the potential pathogenesis of pRBD and its relationship with α-synucleinopathy. In addition, the understanding of psychiatric disorders, notably MDD, is often limited by its heterogeneity. Our proposed study will, by determining the familial aggregation of pRBD, help us to identify certain subtype of the psychiatric populations who may likely harbour an underlying neurodegenerative basis. By using a family study design, a number of important aspects with regard to the pathogenesis of pRBD will be answered. First, if first-degree relatives (FDRs) of patients with pRBD have a higher rate of possible RBD or clinical diagnosis of RBD (as confirmed by video-polysomnography) as well as the presence of neurodegenerative diseases when compared with FDRs of controls, it will substantiate the argument that pRBD is not merely a side effect of antidepressants but rather harbouring a familial and genetic predisposition to RBD and, ultimately α-synucleinopathy neurodegeneration. Second, the determination of biomarkers of neurodegeneration among unaffected FDRs of patients with pRBD will also help to identify high-risk individuals for clinical intervention and prevention. Third, the calculation of heritability will help to delineate to which extent the additive genetic contribution is responsible for the variance of pRBD phenotypes. Finally, the findings from this proposed study will be compared with our on-going family study of typical iRBD to determine the extent to which iRBD and pRBD are similar or different to each other in terms of genetic and familial associations.
In this proposed study, the investigators hypothesize that:
- FDRs of patients with pRBD have a higher rate of RBD symptoms and its core features compared with FDRs of controls;
- The unaffected FDRs of patients with pRBD are more likely to exhibit the features associated with prodromal markers of Parkinson's disease compared with FDRs of controls;
- FDRs of patients with pRBD have a higher rate of Parkinson's disease (and other α-synucleinopathy neurodegeneration) compared with FDRs of controls.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychiatric RBD cases | – | –1. Presence of REM sleep without atonia; 2. At least one of the followings is present: i). Dream enactment behaviors, SRIs, potentially injurious or disruptive behaviors by history; ii). Abnormal REM sleep behaviors documented during v-PSG monitoring; 3. Absence of electroencephalogram (EEG) epileptiform activity during REM sleep unless RBD can be clearly distinguished from any concurrent REM sleep related seizure disorder; 4. The sleep disturbance is not better explained by other sleep disorder (e.g., obstructive sleep apnea, medical or neurological disorder, mental disorder, medication use, or substance use disorder) |
| Psychiatric control | – | –1. Age- and sex- matched with pRBD proband; 2. Concurrent psychiatric illnesses according to the Mini International Neuropsychiatric Interview( M.I.N.I); 3. Free of narcolepsy and other neurological diseases; 4. Absence of any RBD features as based on REM sleep behavior disorder questionnaire (RBDQ-HK) and v-PSG; 5) Free of neurodegenerative diseases |
| Healthy control | – | –1. Age- and sex- matched with pRBD proband; 2. Without lifetime psychiatric disorder according to Mini International Neuropsychiatric Interview( M.I.N.I); 3. Free of narcolepsy and other neurological diseases; 4. Absence of any RBD features as based on RBDQ-HK and v-PSG; 5. Free of neurodegenerative diseases |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we will employ a combination of family history (proxy report for unavailable/inaccessible subjects) and study (face-to face interview, clinical and sleep study) method in determining the familial aggregation of pRBD. The flowchart of subject recruitments is presented in Figure 1. The study subjects are the FDRs of pRBD cases, psychiatric controls and healthy controls. As previous studies have suggested that depression is a significant risk factor of development of Parkinson's Disease, we will include two control groups. First, those FDRs of patients with psychiatric disorders in addition to the FDRs of healthy controls (free of depression and RBD), in consideration of the potential associations of proband's psychiatric disorders with prodromal markers of Parkinson's Disease in the FDRs.
Key inclusion criteria (5 listed)
- Age- and sex- matched with pRBD proband;
- Without lifetime psychiatric disorder according to Structural Clinical Interview for DSM-IV Disorders (SCID);
- Free of narcolepsy and other neurological diseases;
- Absence of any RBD features as based on RBDQ-HK and v-PSG;
- free of neurodegenerative diseases.
Key exclusion criteria (3 listed)
- Not Chinese or aged under 40 years old;
- Refuse to participate in this study;
- without a biological relationship with proband.
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
Prevalence of possible REM Sleep Behavior Disorder
Time frame: 17 months
The prevalence of possible REM Sleep Behavior Disorder based on the self-reported/proxy-reported REM Sleep Behavior Disorder symptoms in REM Sleep Behavior Disorder Questionnaire-HK among First Degree Relatives,
3 secondary outcomes
Percentage of REM-related EMG activity
Time frame: 17 months
Weighted prevalence of Polysomnography confirmed REM Sleep Behavior Disorder
Time frame: 17 months
Recurrence risk of Parkinson's disease
Time frame: 17 months
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 28 Oct 2022.
- Derived from this study: PubMed 37399287Wang J, Lam SP, Huang B, Liu Y, Zhang J, Yu MWM, Tsang JCC, Zhou L, Chau SWH, Chan NY, Chan JWY, Schenck CH, Li SX, Mok VCT, Ma KKY, Chan AYY, Wing YK. Familial alpha-synucleinopathy spectrum features in patients with psychiatric REM sleep behaviour disorder. J Neurol Neurosurg Psychiatry. 2023 Nov;94(11):893-903. doi: 10.1136/jnnp-2022-330922. Epub 2023 Jun 30.
- Individual participant dataSharing planned: Undecided. In this stage, the investigators 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.
Yun Kwok Wing, Professor principal investigator
Chinese University of Hong Kong
2 sites 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 2 sites 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 5 inclusion and 3 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence of possible REM Sleep Behavior Disorder (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595475, which also lists 1 linked publication.
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 28 Oct 2022.