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Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

NCT ID: NCT03376568

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-28

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Narcolepsy REM Sleep Behavior Disorder

Keywords

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polysomnographic multiple sleep latency test fMRI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Narcolepsy with RBD & Control

Narcolepsy with REM sleep disorder lable(20) and Control subjects lable(20)

No interventions assigned to this group

Narcolepsy with /without RBD

Narcolepsy with REM sleep disorder lable(20) and Narcolepsy without REM sleep disorderlable (20)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guoyan Chen, MD

Role: CONTACT

Phone: 86-02984717792

Email: [email protected]

Wen Wang, PhD

Role: CONTACT

Phone: 86-02984778689

Email: [email protected]

Facility Contacts

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Guoyan Chen, MD

Role: primary

Wen Wang, PhD

Role: backup

Other Identifiers

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TDLL-201601-08

Identifier Type: -

Identifier Source: org_study_id