Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Information source: Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
Intervention: Mometasone furoate nasal spray (Drug); Placebo (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Children's & Women's Health Centre of British Columbia
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.
Clinical Details
Official title: A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Apnea Hypopnea Index (AHI)
Secondary outcome: Respiratory Disturbance IndexDesaturation index Respiratory arousal index Nadir of arterial oxygen saturation Mean arterial oxygen saturation Avoidance of surgical treatment for OSA Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.) Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])
Eligibility
Minimum age: 3 Years.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
BC Women's and Children's Hospital, Vancouver, British Columbia V6H 3N1, Canada
Additional Information
Starting date: May 2012
Last updated: July 28, 2015
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