Condition category
Mental and Behavioural Disorders
Date applied
11/10/2018
Date assigned
24/10/2018
Last edited
31/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD) is a parasomnia, which is unusual nervous system activity during sleep. iRBD presents as limb movements, which often appear to act out the content of undesirable dreams. Patients and relatives complain about iRBD symptoms such as shouting, gesturing, leaping out of bed, or punching bed partners. iRBD is receiving increased attention as an important risk factor for the future development of neurodegenerative disorders, such as Parkinson’s disease (PD). The cause remains unclear in iRBD patients. iRBD development is likely to stem from abnormalities in the structure of the brain. The development of imaging technology provides a new way to study such diseases, including functional and structural imaging. Functional imaging studies have reported that iRBD patients have regional cerebral perfusion and glucose metabolic changes. We aim to detect the changes in the structure of the brain, and find structural changes related to clinical indices in patients with iRBD. Our study’s findings should provide more structural evidence for cerebral functional changes in this population.

Who can participate?
Adults who are diagnosed with iRBD at the Sleep and Wake Disorders Center in China

What does the study involve?
Patients will undertake the overnight polysomnographic (PSG) recordings. Only those patients who meet the clinical and PSG diagnosis criteria for iRBD can join this study. Patients will also receive a neurological examination and undertake various questionnaires. Besides, patients should receive the neurologic examination, Unified Parkinson’s Disease Rating Scale motor rating (UPDRS III) and Mini-Mental State Examination (MMSE) score. All participants will also undertake high-resolution, structural MRI scans.

What are the possible benefits and risks of participating?
This study can expand the spectrum of reported structural changes in iRBD patients, having implications for the future research about such disease. In this study, iRBD patients can obtain the latest information about the progression of their disease, with no radiation. Based on the clinical and imaging data, patients may regulate therapeutic plans to produce a better curative effect. There will be no immediate direct risk to those taking part. The main discomfort of taking MRI is loud noise during the scans.

Where is the study run from?
Sleep and Wake Disorders Center of the Department of Neurology and Radiology Department of Huashan Hospital, Fudan University (China)

When is the study starting and how long is it expected to run for?
January 2014 to December 2015

Who is funding the study?
1. China-US Biomedical Collaborative Research Program (USA, China)
2. National Natural Science Foundation of China (China)
3. Shanghai Sailing Program (China)

Who is the main contact?
Dr Xian-Hua Han
xhhan_2015@126.com

Trial website

Contact information

Type

Public

Primary contact

Dr Xian-Hua Han

ORCID ID

Contact details

No.12
Urumqi Middle Road
Jing'an District
Shanghai
200040
China
+86 (0)15802117087
xhhan_2015@126.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Exploring cerebral structural alterations using MRI and determining their association with clinical parameters in Idiopathic rapid eye movement sleep behavior disorder (iRBD) patients

Acronym

Study hypothesis

To investigate the gray matter volume (GMV) changes, and the relationships between GMV and clinical indices, in iRBD patients.

Ethics approval

The Ethics Committee of Huashan Hospital, 04/01/2014, ref: KY2013-336

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Idiopathic rapid eye movement sleep behavior disorder

Intervention

All iRBD patients underwent one night (8 hours) of audio-video-PSG monitoring. All MRI measurements were obtained on a 3-tesla GE Discovery MR750 Scanner for ~30minutes. Brain structural T1-weighted MRI scans was acquired from all 39 participants. Gray matter volume (GMV) data were analyzed based on Statistical Parametric Mapping 8, using a voxel-based morphometry method and two-sample t-test and multiple regression analysis. No follow-up data were obtained due to the nature of study design.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Gray matter volume, assessed by MRI scans for 30 minutes at the study visit

Secondary outcome measures

Polysomnography monitoring over one night for 8 hours to assess:
1. Total sleep duration
2. Sleep efficiency
3. Stage 1 non-rapid eye movement (NREM)
4. Stage 2 NREM
5. Rapid eye movement sleep time
6. Apnea-hypopnea index
7. Phasic electromyography (EMG) activity index
8. Tonic EMG activity
9. Spontaneous microarousal index
10. Periodic limb movements in sleep

Overall trial start date

02/01/2014

Overall trial end date

10/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18–65 years
2. Diagnosed with iRBD according to the clinical and polysomnographic (PSG) characteristics

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

39

Participant exclusion criteria

1. Signs of parkinsonism
2. Treated with psychotropic medications
3. Evidence of psychiatric disorders or dementia
4. Any cognitive impairment
5. Drug-induced iRBD
6. Sleep apnea syndrome
7. Electroencephalograph (EEG) abnormalities suggestive of epilepsy, central nervous system comorbidities such as brain tumor, encephalitis, unstable hypertension, and diabetes

Recruitment start date

06/03/2014

Recruitment end date

08/04/2015

Locations

Countries of recruitment

China

Trial participating centre

Huashan Hospital, Fudan University
No.12, Urumqi Middle Road, Jing'an District
Shanghai
200040
China

Sponsor information

Organisation

Huashan Hospital, Fudan University

Sponsor details

No.12
Urumqi Middle Road
Jing'an District
Shanghai
200040
China
+86 (0)21 52889999
huashanyz@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

China-US Biomedical Collaborative Research Program, No. 81361120393

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Natural Science Foundation of China, No. 81401135, 81671239

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, Chinese National Science Foundation, NSFC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

China

Funder name

Shanghai Sailing Program, No. 18YF1403100.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
Individual participant data that underlie the results reported in this article will be published in a peer-reviewed journal, after deidentification (text, tables, figures, and appendices). It will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to zuoct_cn2000@126.com. To gain access, data requestors will need to sign a data access agreement. The study protocol, statistical analysis plan and informed consent form will also be available from 3 months up to 5 years following article publication.

Intention to publish date

10/12/2016

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30688273

Publication citations

Additional files

Editorial Notes

31/01/2019: Publication reference added. 02/11/2018: Internal review.