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NCT03376568 Clinical Trial

Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

Narcolepsy Clinical Trial

Official title:
Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03376568
Other study ID # TDLL-201601-08
Secondary ID
Status Recruiting
Phase N/A
First received December 4, 2017
Last updated December 15, 2017
Start date January 28, 2016
Est. completion date December 30, 2019

Study information
Verified date December 2017
Source Tang-Du Hospital
Contact Guoyan Chen, MD
Phone 86-02984717792
Email chenguoyan29@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 30, 2019
Est. primary completion date December 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 65 Years
Eligibility 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?/h History of alcohol dependence and drug abuse

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Tangdu Hospital Xi'an Shan

Sponsors (1)
Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary video-polysomnographic(PSG) video-PSG monitor sleep from 9:00pm to 6:00am up to 100 weeks
Secondary multiple sleep latency test (MSLT) MSLT in the next day of PSG record daytime sleepiness up to 100 weeks
Secondary functional magnetic resonance imaging (fMRI) All narcolepsy with or withoutRBD accepts fMRI up to 100 weeks
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