Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Phase 4

• Conditions: Sleep Disordered Breathing

• Registration Number: NCT00299910
• Lead Sponsor: Soroka University Medical Center

Brief Summary

This study will assess in a double blind placebo controlled fashion the effects of a 12 week course of oral montelukast/placebo on polysomnographic and radiological findings and will characterize the systemic (serum,urine) and local (upper airway collected biological samples) inflammatory response in children (2-10 years of age) with sleep disordered breathing, fittingthe inclusion and exclusion criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-07
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-20
• Last Update Posted: 2008-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

2-10 years old

1<AHI<8 measured in an overnight PSG

Exclusion Criteria

Asthma Previous use or allergy to montelukast Use of antibiotics in the previous 3 weeks Use of corticosteroids in the previous 3 months Craniofacial dysmorphism Genetic or metabolic defined illnesses Adenotonsillectomy or adenoidectomy in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Pediatric Sleep Center, Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel