Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

Study Overview
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Brief Summary
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The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.

Detailed Description
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The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.

Official Title
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Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Drug: budesonide (Aircort 50 nasal spray)
* Drug: montelukast (Singulair)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mild (RDI 3- <5) or moderate obstructive apneas (RDI 5-8) by overnight polysomnographic evaluation with 4 channels EEG Adenotonsillar hypertrophy Friedman score's II-III-IV° Exclusion Criteria: Neuromuscular, gastrointestinal, neurological diseases and syndromes of malformations Use of leukotrienes and/or nasal and oral steroids in the 4 weeks preceding the initial sleep study Acute upper respiratory tract infections Adenotonsillectomy

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal steroid<br> | Drug: budesonide (Aircort 50 nasal spray)<br>* 50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months<br>* Other names: Aircort 50 nasal spray;|
| Active Comparator: Anti-leukotrienes<br> | Drug: montelukast (Singulair)<br>* Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older<br>* Other names: Singulair;|
| Active Comparator: Nasal steroid + anti-leukotrienes<br> | Drug: budesonide (Aircort 50 nasal spray)<br>* 50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months<br>* Other names: Aircort 50 nasal spray;Drug: montelukast (Singulair)<br>* Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older<br>* Other names: Singulair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment: |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical upper airway patency during the night in the patients with history of allergic rhinitis compared with the patients without history of allergic rhinitis first and after the treatment for OSAS |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polysomnography, obstructive sleep apnea syndrome, snoring, adenotonsillar hypertrophy, intranasal steroids, Anti-leukotrienes