Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

• Conditions: REM Sleep Behavior Disorder; Narcolepsy

• Registration Number: NCT03376568
• Lead Sponsor: Tang-Du Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-01-28
• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-15
• Last Update Submitted: 2017-12-15
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18
• Primary Completion: 2017-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
video-polysomnographic(PSG)	up to 100 weeks	video-PSG monitor sleep from 9:00pm to 6:00am

Secondary Outcome Measures

Name	Time	Method
multiple sleep latency test (MSLT)	up to 100 weeks	MSLT in the next day of PSG record daytime sleepiness
functional magnetic resonance imaging (fMRI)	up to 100 weeks	All narcolepsy with or withoutRBD accepts fMRI

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shan, China