Medical vs Surgical Treatment in OSA Among Children

Study Overview
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Brief Summary
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Adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy [9]. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required. . adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required.

Official Title
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Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire

Conditions
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To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy, To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results

Intervention / Treatment
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* Drug: Montelukast
* Drug: Fluticasone Furoate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children between 2-16 years of age referred to the pediatric otolaryngology outpatient clinic due to OSA and have not undergone previous adeno-tonsillar procedure Exclusion Criteria: children with severe OSA who need an urgent surgery and cannot be postponed, children with nasal polyposis, craniofacial malformations (e.g. cleft lip and palate), and genetic diseases (e.g. Down syndrome).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Montelukast tab<br> | Drug: Montelukast<br>* receiving 2 months treatment with Montelukast once a day<br>* Other names: Singulair;|
| Experimental: Fluticasone nasal spray<br> | Drug: Fluticasone Furoate<br>* receiving 2 months treatment with Fluticasone Furoate nasal spray once a day<br>* Other names: Avamys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine clinical response to montelukast or nasal steroids based on PSQ results |  | 1 year |