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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Budesonide; Leukotriene Antagonists; Montelukast

Criteria

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