Status:

UNKNOWN

Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder

Lead Sponsor:

Chinese University of Hong Kong

Conditions:

REM Sleep Behavior Disorder

Neurodegeneration

Eligibility:

All Genders

50+ years

Brief 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...

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 t...

Eligibility Criteria

Inclusion

  • 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;
  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 15 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2022

Estimated Enrollment :

182 Patients enrolled

Trial Details

Trial ID

NCT04048603

Start Date

May 15 2019

End Date

October 1 2022

Last Update

August 6 2021

Active Locations (1)

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

Hong Kong, Hong Kong