NCT03660982

Brief 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 unaffected first degree relatives of RBD cases and non-RBD controls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

8 years

First QC Date

August 30, 2018

Last Update Submit

August 5, 2021

Conditions

REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    one night (8 hours)

Secondary Outcomes (3)

  • The percentage of REM-related EMG activity (REMREEA)

    one night (8 hours)

  • Significant motor activity

    one night (8 hours)

  • Other biomarkers of RBD in the first degree relatives of RBD patients.

    2 hours

Study Arms (2)

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.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Chinese aged 40 or above;
  • Being capable of giving informed consent for participation of the study;
  • Sex matched between relatives from probands and controls.

You may not qualify if:

  • Aged 39 or below;
  • Not capable of giving informed consent for participation of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

TFT-SEP Serum Clot, Vitamin B12-SEP Serum clot, Folate- SEP Serum clot, CBC-EDTA, Fasting Glucose-Fluoride

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jihui Zhang, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Yun Kwok Wing, MBChB

    Chinese University of Hong Kong

    STUDY DIRECTOR

  • Siuping LAM

    Chinese University of Hong Kong

    STUDY DIRECTOR

  • Vicent Chung-tong MOK

    Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Jihui Zhang, PhD

CONTACT

(852) 39197647jihui.zhang@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 7, 2018

Study Start

October 1, 2014

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

HK(1)