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REM Sleep Behavior DisorderNCT03353207

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

An observational study of REM Sleep Behavior Disorder and Neurodegenerative Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
How many people
50 participants
Where
1 siteHong Kong
Study dates
30 Oct 2017to 8 Feb 2021
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects will be identified and recruited from our previous cohort.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Shatin Hospital

    Shatin

Other trials in Hong Kong

About this study

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

Read more

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

In the past two decades, a number of studies have confirmed that most patients with idiopathic RBD will eventually develop neurodegenerative diseases, especially α-synucleinopathies. Previous studies, including our preliminary data, suggested that RSWA is a marker of predicting the conversion of neurodegenerative diseases in idiopathic RBD. In other words, RSWA is an early marker of neurodegeneration in patients with idiopathic RBD. However, a number of individuals who are absent of any RBD symptoms (including patients with α-synucleinopathies, also have RSWA, which is described to have isolated RSWA. Only a few studies have attempted to understand the clinical importance and predictive prognosis of isolated RSWA. These preliminary studies suggest that isolated RSWA in healthy subjects may be a silent biomarker of neurodegeneration. However, these preliminary findings need to be replicated and confirmed by more refined study with dopamine neurotransmission neuroimaging.

This proposed study will enrich the limited scientific literature of the potential pathogenesis and progression of isolated RSWA. By using an ongoing family study, we have screened a number of individuals with isolated RSWA, who are the first degree relatives of patients with RBD and are presumed to have a higher risk of neurodegeneration. Based on the existing sample, the current study will provide the first neuroimaging data on isolated RSWA to test the hypothesis that isolated RSWA, even in the absence of RBD symptoms, is an early marker of neurodegeneration. Individuals with isolated RSWA are expected to show dopamine dysfunction when compared with individuals without RSWA. If we confirm this hypothesis, the findings in the current study will extend our understanding of the spectrum of RBD and RSWA. The potential implication of our findings is that asymptomatic RSWA, especially in the presence of family history, will harbour the neurodegenerative progression. The results will pave the way for future prospective follow up to determine the course of neurodegeneration. From an etiological understanding, it will help to expand the understanding of the evolution course of synucleinopathy neurodegeneration. From an interventional angle, this study will have significant implication for developing a longer prevention window for neuroprotective trial.

The inclusion criteria for the subjects:

iRBD first degree relatives 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.

Community-based health controls without isolated RSWA:

  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.
Keywords
REM Sleep Without Atonia, Dopamine transmission, Neurodegeneration
Medical subject headings
REM Sleep Behavior Disorder, Neurodegenerative Diseases, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03353207
Study groupRoleWhat they receive
health Control1. 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 RSWA1. 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 RSWA1. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dopamine neurotransmission

    PET dopamine neurotransmission with a specific interest in striatal dopamine transmission

    Measured: 24 months

Secondary outcomes (1)
  1. REMREEA

    Correlations of severity of REMREEA with dopamine transmission, brain glucose metabolism, and neurocognitive measures.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start30 Oct 2017
  3. Primary completion1 Jul 2019
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353207
Sponsor's protocol ID
HMRF04153036
Status last verified
Feb 2021
First submitted
21 Nov 2017
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: In this stage, we didin't decide which information of IPD will share with other researchers

Questions about this trial

What is this clinical trial studying?

An observational study of REM Sleep Behavior Disorder and Neurodegenerative Diseases, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dopamine neurotransmission (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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