Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
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|ClinicalTrials.gov Identifier: NCT03376568|
Recruitment Status : Unknown
Verified December 2017 by Tang-Du Hospital.
Recruitment status was: Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
|Condition or disease|
|Narcolepsy REM Sleep Behavior Disorder|
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 :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject|
|Actual Study Start Date :||January 28, 2016|
|Estimated Primary Completion Date :||December 30, 2017|
|Estimated Study Completion Date :||December 30, 2019|
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)
- video-polysomnographic(PSG) [ Time Frame: up to 100 weeks ]video-PSG monitor sleep from 9:00pm to 6:00am
- multiple sleep latency test (MSLT) [ Time Frame: up to 100 weeks ]MSLT in the next day of PSG record daytime sleepiness
- functional magnetic resonance imaging (fMRI) [ Time Frame: up to 100 weeks ]All narcolepsy with or withoutRBD accepts fMRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376568
|Contact: Guoyan Chen, MDemail@example.com|
|Contact: Wen Wang, PhDfirstname.lastname@example.org|