Clinical trial NCT01671852: Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Official title: A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe) as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed apneas and obstructive hypopneas).

Exclusion Criteria:

* Children with malformation syndromes or craniofacial anomalies
* Children with neuromuscular disorders
* Children with morbid obesity (body mass index ≥ 40)
* Children with asthma requiring steroid treatment

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Respiratory Disturbance Index
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Desaturation index
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Respiratory arousal index
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Nadir of arterial oxygen saturation
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Mean arterial oxygen saturation
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Avoidance of surgical treatment for OSA
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.)
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
measure: Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])
timeFrame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's and Children's Hospital
state: British Columbia
Study officials:
References: