Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Status:
Withdrawn
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Children's & Women's Health Centre of British Columbia