NCT00599534

Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\&A for OSAS. \- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.

Detailed description

Primary Specific Aim. To conduct a randomized double blind 16-week trial comparing the effect on polysomnographic measures of the administration of once a day oral montelukast therapy vs. placebo in children with OSAS. Secondary Specific Aim. For all children with the original AHI at diagnosis of \>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DRUG	Montelukast	4 mg oral tablets
DRUG	Placebo	5mg tablets

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-01-23
• Last updated: 2017-04-10

Locations

2 sites across 1 country: United States