Clinical trial NCT03660982: Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.
Official title: Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder: a Case-control Family Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: REM Sleep Behavior Disorder
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Aged 39 or below;
2. Not capable of giving informed consent for participation of the study

Primary outcomes:
measure: The prevalence rate of probable RBD among first degree relatives of RBD probands
timeFrame: 15 minutes
measure: The weighted prevalence rate of confirmed RBD among first degree relatives of RBD probands.
timeFrame: one night (8 hours)
Secondary outcomes:
measure: The percentage of REM-related EMG activity (REMREEA)
timeFrame: one night (8 hours)
measure: Significant motor activity
timeFrame: one night (8 hours)
measure: Other biomarkers of RBD in the first degree relatives of RBD patients.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Jihui Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Yun Kwok Wing, MBChB
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Siuping LAM
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Vicent Chung-tong MOK
role: STUDY_DIRECTOR
References: