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

Soroka University Medical Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Disordered Breathing

Interventions

MontelukastDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Pediatric Sleep Center, Soroka University Medical Center

Beersheba, Israel

RECRUITING

Central Contacts

Aviv D Goldbart, MD, MSc

CONTACT

972-8-6403400 avivgold@bgu.ac.il

Data from ClinicalTrials.gov

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