Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration

NCT03353207 | Completed

• 1 other identifier: HMRF04153036
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.The dopamine transmission as measured by triple-tracer PET/ CT imaging protocol including 18F-DOPA, 11C-Raclopride and 18F-FDG images;
2. 2.Brain glucose metabolism and neurocognitive measures;
3. 3.Severity of EMG activity during REM sleep

Conditions

REM Sleep Behavior Disorder; Neurodegenerative Diseases

Keywords

REM Sleep Without Atonia; Dopamine transmission; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• Dopamine neurotransmission

  PET dopamine neurotransmission with a specific interest in striatal dopamine transmission

  24 months

Secondary Outcomes (1)

• REMREEA

  24 months

Study Arms (3)

health Control

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.

Case with isolated 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.

Case without isolated 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.

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be identified and recruited from our previous cohort.

You may qualify if:

• No family history of RBD;
• Age- and sex- matched with isolated RSWA subjects
• Absence of dream enactment behaviors;
• A score of RBDQ-HK less than 19;
• Absence of RSWA as measured by v-PSG;
• 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.

You may not qualify if:

• Presence of dream enactment behaviors by self-report or documented by v-PSG;
• Presence of narcolepsy and other neurological diseases that may give rise to RBD and RWSA;
• Presence of neurodegenerative diseases;
• A total score of the MOCA ≤ 22 and the CDR ≥ 1.
• On medication that potentially increases EMG activity and triggers the symptoms of RBD, such as antidepressants;
• On medication that affects dopamine neural transmission;
• Not capable of giving informed consent for participation of the study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Shatin Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Neurodegenerative Diseases; Nerve Degeneration

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun Kwok Wing, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: October 30, 2017
• Primary Completion: July 1, 2019
• Study Completion: February 8, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

HK (1)