Normal Polysomnography Values in Healthy Children and Adolescents in China (PSGNV)

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Capital Medical University

Status

Unknown

Conditions

Sleep Apnea

Study type

Observational

Funder types

Other

Identifiers

NCT02761902
BCH-OSAHS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

3 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

180 participants in 3 patient groups

Preschool group
Description:
3-6 years old
school age group
Description:
7-12 years old
Adolescence group
Description:
13-15 years old

Trial contacts and locations

1

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Central trial contact

Xiaodan Li, MD; Zhifei Xu, MD,PHD

Data sourced from clinicaltrials.gov

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