Clinical trial NCT02447614: Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children
Official title: Follow-up Studies of PS and OSAHS in Chinese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: follow up
Primary Snoring
Obstructive Sleep Apnea Syndrome
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PS and OSAHS in Chinese children

Brief summary: The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.

Detailed description: The evolution of snoring and OSAS in children is not well established since few studies have been published.This study is designed to evaluate the evolution of primary snoring and OSAS in children who had been submitted to watchful waiting 、drug or adenotonsillectomy.The participated children will be evaluated by full physical examination and nocturnal polysomnography（PSG）, after which they were divided into 2 groups: apnea and snoring. After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination.And after 3 months and 12 months following the initial evaluation, patients will be called to complete the sleep questionnaire.Then analyse the change of parameters of polysomnography after 6 months of follow-up,and describe the changes of items of sleep questionnaire.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.

Exclusion Criteria:

* Children who are suffered from any chronic medical or psychiatric condition
* Children with acute respiratory infection
* Children with severe craniofacial deformities
* Children with cardiopulmonary diseases
* Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

Primary outcomes:
measure: The changes of PSG parameters of children with PS or OSAS
timeFrame: 6 months
Secondary outcomes:
measure: The changes of sleep questionnaires of children with PS or OSAS
timeFrame: 3 months, 6 months, 12 months
measure: The changes of level of leukotriene in urine of children with PS or OSAS
timeFrame: 6 months
measure: The high-sensitivity CRP and Heart rate variability (HRV) of children with SDB
timeFrame: 0 months
Other outcomes:
measure: The pictorial memory task acquisition and retention in children with SDB
timeFrame: 0 month
measure: The endothelial cell function in children with PS or OSAS
timeFrame: 0 month
Locations:
city: Beijing
country: China
facility: Sleep Center,Beijing Children's Hospital
Study officials:
affiliation: Beijing Children's Hospital
name: Xu Zhifei, MD,PhD
role: STUDY_DIRECTOR
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