Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
2-10 years old
1<AHI<8 measured in an overnight PSG
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pediatric Sleep Center, Soroka University Medical Center
🇮🇱Beer-Sheva, Israel