Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follow-up Studies of PS and OSAHS in Chinese Children

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Procedure: Adenotonsillectomy
* Other: Conservative treatment
* Other: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery<br>Adenotonsillectomy | Procedure: Adenotonsillectomy<br>* Adenotonsillectomy<br>|
| Conservative treatment<br>Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists | Other: Conservative treatment<br>* Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists<br>|
| no treatment<br>just regular follow-up | Other: no treatment<br>* just regular follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of PSG parameters of children with PS or OSAS | In our study, there are 55 children of mild to moderate SDB with conservative treatment, among which 23 children are chosen in PS group and 32 children are chosen in OSAS group. For PSG, according to the value of OAHI to determine the improvement of the child, the value of OAHI is decreased by ≥ 25% for improvement. In the PS group, there were 2 cases with improvement, and the corresponding remission rate was 8.7%. In the OSAS group, there are 22 cases with improvement, and the corresponding remission rate was 68.8%. There was a significant difference between the remission rate of PS group and that of OSAS group (P<0.001). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of sleep questionnaires of children with PS or OSAS | There are five impact factors in the PSQ questionnaire, including: 1) nighttime snoring related symptoms (S); 2) sleep accompanying symptoms and related diseases (A); 3) daytime sleepiness related symptoms (L); 4) behavior related symptoms (B); and 5) others' evaluation of children's sleep (O). In the PS group, there were significant difference for factor S, A and B at the time of 3 months and one year. For factor L, there was significant change at 3 months, while there was no significant change at half the year and one year. In the OSAS group, there was significant change in the S factor for 3 months, half the year, and one year. While for the O factor, there was no significant change in any time. For factor A and L, there was a significant change in 3 months and one year. For the B factor, there was a significant difference at one year. | 3 months, 6 months, 12 months | 
| The changes of level of leukotriene in urine of children with PS or OSAS | There was no significant difference in the level of leukotriene between PS and OSAS group. Also no significant difference in the level of leukotriene was detected among waiting, conservative or surgery group. | 6 months | 
| The high-sensitivity CRP and Heart rate variability (HRV) of children with SDB | The controls were elder. Children in moderate-severe OSAS group were more boys and more obese. Because of the disease itself, there was statistic difference in AHI, OAI, ODI, respiratoryrelatedarousal index (ArI-resp), average SpO2 and lowest SpO2 among groups.The percentage of high level hs-CRP varied with the severity of SDB and cochran armitage trend test showed statistical significance (Z=-2.5109, p=0.012). In logistic regression analysis, OSAS, otitis media and BMI-z score were independent risk factors for high level hs-CRPafter adjusting for age and gender( p<0.0001). In multiple linear regression,after removing theconfounding factor of OSAS, it showed that high level hs-CRP was negatively correlated with SDNN, RMSSD, LF and HF respectively (p=0.003, p<0.001, p=0.007 and p=0.003 respectively). | 0 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow up, Primary Snoring, Obstructive Sleep Apnea Syndrome