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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03376568

Enrollment

100

Registered

2017-12-18

Start date

2016-01-28

Completion date

2019-12-30

Last updated

2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, REM Sleep Behavior Disorder

Keywords

polysomnographic, multiple sleep latency test, fMRI

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

10 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactGuoyan Chen, MD

chenguoyan29@126.com86-02984717792

Backup ContactWen Wang, PhD

wangwen@fmmu.edu.cn86-02984778689

Outcome results