Investigation of Clinical Feature and Brain Function in N... | NCT03376568

Studies
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

NCT03376568

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Dec 18, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Narcolepsy
REM Sleep Behavior Disorder

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2016Actual

Primary Completion Date

Dec 30, 2017Estimated

Completion Date

Dec 30, 2019Estimated

First Submitted Date

Dec 4, 2017

First Submission Date that Met QC Criteria

Dec 15, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2017

Last Update Posted Date

Dec 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guoyan Chen, MD	Contact	86-02984717792		chenguoyan29@126.com
Wen Wang, PhD	Contact	86-02984778689		wangwen@fmmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tangdu Hospital	Recruiting	Xi'an	Shaanxi	710000	China

Condition Browse Module

MeSH Terms

ID	Term
D009290	Narcolepsy
D020187	REM Sleep Behavior Disorder

Ancestor Terms

ID	Term
D006970	Disorders of Excessive Somnolence
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided