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

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

Study Overview

• Status: Unknown
• Conditions: REM Sleep Behavior Disorder; Narcolepsy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shan
    • Xi'an, Shan, China, 710000
      • Recruiting
      • Tangdu Hospital
      • Contact: Guoyan Chen, MD; Phone Number: 86-02984717792; Email: chenguoyan29@126.com
      • Contact: Wen Wang, PhD; Phone Number: 86-029778689; Email: wangwen@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will need about 40 narcoleptic patients with /without RBD between 10 and 65 years of age,and about 20 age- and gender-matched control subjects.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Anticipated): December 30, 2017
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: fMRI; polysomnographic; multiple sleep latency test
• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Disorders of Excessive Somnolence; Mental Disorders; REM Sleep Behavior Disorder; Narcolepsy
• Other Study ID Numbers: TDLL-201601-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No