Montelukast for mild OSA in childre

Phase 3

• Conditions: Mild obstructive sleep apnoea (OSA) in children; Respiratory - Sleep apnoea

• Registration Number: ACTRN12607000245493
• Lead Sponsor: School of Women's and Children's Health, University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mixed & obstructive apnoea/hypopoea index (MOAHI) as measured by polysomnography (PSG)[At the end of the 8 week treatment period.]

Secondary Outcome Measures

Name	Time	Method
Quality of life, measures of behaviour, attention, and cognition.[Measured at baseline and at the end of the 8 week treatment period.]