Normal Polysomnography Values in Healthy Children and Ado... | NCT02761902

Studies
Normal Polysomnography Values in Healthy Children and Adolescents in China

NCT02761902

Sponsor

Beijing Children's Hospital

Status

Unknown status

Last Update Posted

May 4, 2016Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Sleep Apnea

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

May 2016

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

Feb 2015

Primary Completion Date

May 2016Estimated

Completion Date

May 2016Estimated

First Submitted Date

May 2, 2016

First Submission Date that Met QC Criteria

May 2, 2016

First Posted Date

May 4, 2016Estimated

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

May 2, 2016

Last Update Posted Date

May 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.

Detailed Description

We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.

Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preschool group		3-6 years old
school age group		7-12 years old
Adolescence group		13-15 years old

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
obstructive apneas per hour of sleep		7 hours of sleep

Secondary Outcomes

Measure	Description	Time Frame
minimum oxygen desaturation of sleep		7 hours of sleep
central apneas per hour of sleep		7 hours of sleep

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.3 to 14-year-old children 2.from the community of China 3.healty children

Exclusion Criteria:

children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
children with history of upper respiratory tract infection nearly two weeks.
children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
children with any medical or surgicaldiseases.
children who have to use use sedation to maintain sleep.
parents or child not understand the study or do not agree to take part in.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

3 to 14-year-old healthy children from the community of China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaodan Li, MD	Contact	86-15210900832		dannylxd1989@163.com
Zhifei Xu, MD,PHD	Contact	86-010-59616395		zhifeixu@aliyun.com

Overall Officials

Name	Affiliation	Role
Xin Ni, MD PHD	Beijing Children's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Sleep Center，Beijing,China	Recruiting	Beijing	Beijing Municipality	100045	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7300438	Background	Guilleminault C, Korobkin R, Winkle R. A review of 50 children with obstructive sleep apnea syndrome. Lung. 1981;159(5):275-87. doi: 10.1007/BF02713925. No abstract available.
6478890	Background	Berry DT, Webb WB, Block AJ. Sleep apnea syndrome. A critical review of the apnea index as a diagnostic criterion. Chest. 1984 Oct;86(4):529-31. doi: 10.1378/chest.86.4.529.

ID	Term
D012891	Sleep Apnea Syndromes
D020181	Sleep Apnea, Obstructive

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic