Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD

Condition or disease
Narcolepsy REM Sleep Behavior Disorder

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. video-polysomnographic(PSG) [ Time Frame: up to 100 weeks ]
    video-PSG monitor sleep from 9:00pm to 6:00am


Secondary Outcome Measures :
  1. multiple sleep latency test (MSLT) [ Time Frame: up to 100 weeks ]
    MSLT in the next day of PSG record daytime sleepiness

  2. functional magnetic resonance imaging (fMRI) [ Time Frame: up to 100 weeks ]
    All narcolepsy with or withoutRBD accepts fMRI


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Guoyan Chen, MD 86-02984717792 chenguoyan29@126.com
Contact: Wen Wang, PhD 86-02984778689 wangwen@fmmu.edu.cn

Locations
Layout table for location information
China, Shan
Tangdu Hospital Recruiting
Xi'an, Shan, China, 710000
Contact: Guoyan Chen, MD    86-02984717792    chenguoyan29@126.com   
Contact: Wen Wang, PhD    86-029778689    wangwen@fmmu.edu.cn   
Sponsors and Collaborators
Tang-Du Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03376568    
Other Study ID Numbers: TDLL-201601-08
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tang-Du Hospital:
polysomnographic
multiple sleep latency test
fMRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Narcolepsy
REM Sleep Behavior Disorder
Mental Disorders
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
REM Sleep Parasomnias
Parasomnias