- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376568
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject
Study Overview
Status
Conditions
Detailed Description
Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.
Functional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)
This study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Guoyan Chen, MD
- Phone Number: 86-02984717792
- Email: chenguoyan29@126.com
Study Contact Backup
- Name: Wen Wang, PhD
- Phone Number: 86-02984778689
- Email: wangwen@fmmu.edu.cn
Study Locations
-
-
Shan
-
Xi'an, Shan, China, 710000
- Recruiting
- Tangdu Hospital
-
Contact:
- Guoyan Chen, MD
- Phone Number: 86-02984717792
- Email: chenguoyan29@126.com
-
Contact:
- Wen Wang, PhD
- Phone Number: 86-029778689
- Email: wangwen@fmmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .
Exclusion Criteria:
History of heart disease History of central nervous system organic psychosis AHI>15次/h History of alcohol dependence and drug abuse
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Narcolepsy with RBD & Control
Narcolepsy with REM sleep disorder lable(20) and Control subjects lable(20)
|
Narcolepsy with /without RBD
Narcolepsy with REM sleep disorder lable(20) and Narcolepsy without REM sleep disorderlable (20)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
video-polysomnographic(PSG)
Time Frame: up to 100 weeks
|
video-PSG monitor sleep from 9:00pm to 6:00am
|
up to 100 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
multiple sleep latency test (MSLT)
Time Frame: up to 100 weeks
|
MSLT in the next day of PSG record daytime sleepiness
|
up to 100 weeks
|
functional magnetic resonance imaging (fMRI)
Time Frame: up to 100 weeks
|
All narcolepsy with or withoutRBD accepts fMRI
|
up to 100 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDLL-201601-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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