Clinical trial NCT02761902: Normal Polysomnography Values in Healthy Children and Adolescents in China
Official title: Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: Children
Polysomnography
sleep
obstructive sleep apnea;
Chinese
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 to 14-year-old healthy children from the community of China

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.

Eligibility criteria: 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.

Primary outcomes:
measure: obstructive apneas per hour of sleep
timeFrame: 7 hours of sleep
Secondary outcomes:
measure: minimum oxygen desaturation of sleep
timeFrame: 7 hours of sleep
measure: central apneas per hour of sleep
timeFrame: 7 hours of sleep
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Sleep Center，Beijing,China
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Xin Ni, MD PHD
role: STUDY_DIRECTOR
References:
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