Normal Polysomnography Values in Healthy Children and Adolescents in China

Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02761902

Acronym

PSGNV

Enrollment

180

Registered

2016-05-04

Start date

2015-02-28

Completion date

2016-05-31

Last updated

2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Children, Polysomnography, sleep, obstructive sleep apnea;, Chinese

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Eligibility

Sex/Gender

ALL

Age

3 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep. 2. children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia. 3. children with history of upper respiratory tract infection nearly two weeks. 4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery. 5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase. 6. children with any medical or surgicaldiseases. 7. children who have to use use sedation to maintain sleep. 8. parents or child not understand the study or do not agree to take part in.

Design outcomes

Primary

Measure	Time frame
obstructive apneas per hour of sleep	7 hours of sleep

Secondary

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

Countries

China

Contacts

Primary ContactXiaodan Li, MD

dannylxd1989@163.com86-15210900832

Backup ContactZhifei Xu, MD,PHD

zhifeixu@aliyun.com86-010-59616395

Outcome results