Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography Clinical Trial
Official title:
A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment