NCT03353207|Completed
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Sponsor study identifier
observational
50
1 country
1
Study Start
October 30, 2017
Actual (reported)Primary Completion
July 1, 2019
Actual (reported)Study Completion
February 8, 2021
Actual (reported)Background: Previous studies have confirmed that most patients with idiopathic REM sleep behaviour disorder (iRBD) eventually develop neurodegenerative diseases. In addition, REM sleep without atonia (RSWA), a hallmark of RBD feature, is a significant predictor of development of neurodegenerative diseases in patients with iRBD. Some preliminary studies have implied that isolated RSWA in the absence of RBD symptoms may also indicate neurodegeneration. However, this speculation needs to be confirmed by more refined study with sophisticated measures in both RSWA and markers of neurodegeneration Objectives: 1) to determine the differences in striatal dopamine transmission and other markers of neurodegeneration among individuals with isolated RSWA and healthy controls; 2) to examine the correlation of severity of RSWA with striatal dopamine transmission. Design: Case-control study Setting: Community-based sample Participants: 1) iRBD first degree relatives with isolated RSWA (n=18) 2) iRBD first degree relatives without isolated RSWA (n=18) 3) Community-based health controls without isolated RSWA (n=18) Main outcome measures:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 8, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2017
Actual (reported)November 21, 2017
Actual (reported)November 27, 2017
Actual (reported)July 1, 2019
Actual (reported)February 8, 2021
Actual (reported)Dopamine neurotransmission
PET dopamine neurotransmission with a specific interest in striatal dopamine transmission
24 months
REMREEA
24 months
1. No family history of RBD; 2. Age- and sex- matched with isolated RSWA subjects 3. Absence of dream enactment behaviors; 4. A score of RBDQ-HK less than 19; 5. Absence of RSWA as measured by v-PSG; 6. for those individuals with moderate obstructive sleep apnea (AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
1. First degree relatives of patients with iRBD; 2. Age 45 years or above; 3. Absence of dream enactment behaviors; 4. A total score on REM Sleep Behavior Questionnaire (RBDQ-HK) less than 19, which is the cut-off suggestive of a diagnosis of RBD; 5. Presence of RSWA as measured by v-PSG; RSWA is defined as the percentage of increased EMG activity (phasic or tonic) at least 10% during REM sleep for any channel. 6. for those individuals with moderate to severe obstructive sleep apnea (apnea-hypopnea index, AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
1. First degree relatives of patients with iRBD; 2. Age- and sex- matched with isolated RSWA subjects; 3. Absence of dream enactment behaviors; 4. A score of RBDQ-HK less than 19; 5. Absence of RSWA as measured by v-PSG; 6. for those individuals with moderate obstructive sleep apnea (AHI \> 15/hour), effective CPAP treatment should be documented and a second night of V-PSG is required to determine RSWA.
Subjects will be identified and recruited from our previous cohort.
Shatin Hospital
Shatin, Hong Kong
Yun Kwok Wing, Professor
Chinese University of Hong Kong
50 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2017
First Posted
November 27, 2017
Study Start
October 30, 2017
Actual (reported)Establish a National Registry of REM Sleep Behavior Disorder
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2019
Actual (reported)Study Completion
February 8, 2021
Actual (reported)Last Updated
February 24, 2021
Record last verified: 2021-02
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