None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a relatively common condition in children with a peak incidence between 2-6 years, coincident with the maximal size of adenotonsillar tissue relative to the upper airway. OSA has effects on neurocognition and behaviour which may be reversed by adenotonsillectomy. However, surgical treatment carries risks which are increased in children with OSA and children under the age of 3 years. Recent studies have suggested that anti-inflammatory treatment with nasal corticosteroids or with anti-leukotriene agents may be an alternative to surgery. Montelukast is an anti-leukotriene receptor antagonist with minimal risk of adverse effects. A randomised double-blind placebo-controlled trial of montelukast for the treatment of OSA related to adenotonsillar hypertrophy in children is proposed. Following a sleep study (PSG) showing mild OSA, children will be randomised to a once daily dose of Montelukast or placebo for 8 weeks. At the end of treatment a repeat sleep study will be performed as well as measures of disease-specific quality of life, behaviour, attention and cognition.
Interventions
Intervention: Montelukast 4mg for children 2-5 years and 5 mg for children older than 5 years, given once in the evening as a chewable tablet for 8 weeks.
Sponsors
School of Women's and Children's Health, University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
History of habitual snoring >= 4 nights per week for at least 6 months, Mixed Obstructive Apnoea-Hypopnoea Index (MOAHI) >1 and = 5 events per hour, Parents give written informed consent.
Exclusion criteria
MOAHI outside the inclusion range, Craniofacial, Neuromuscular, syndromic, developmental or genetic abnormalities, Current or past use of montelukast, Current upper respiratory tract infection, Use of any inhaled or systemic corticosteroids or antibiotics in the past 4 weeks, Previous surgical treatment for OSA or adenotonsillectomy.
Outcome results
None listed