TerminatedPhase 3Phase 4ACTRN12607000245493

Montelukast for mild OSA in children

In children with mild obstructive sleep apnoea, is montelukast more effective than placebo in reducing the mixed and obstructive apnoea/hypopnoea index


Sponsor

School of Women's and Children's Health, University of New South Wales

Enrollment

40 participants

Start Date

Apr 14, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether the medication montelukast (commonly used for asthma) can treat mild obstructive sleep apnea (OSA) in children. It is for children aged 2 to 10 who snore regularly and have been diagnosed with mild OSA through a sleep study. Participation involves taking montelukast daily and having follow-up sleep studies to check for improvement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.

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.


Locations(1)

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000245493