View Clinical Trial (Medical Research Study)
A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Obstructive Sleep Apnea |
| Purpose: |
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The investigators leading hypotheses are:
- Oral therapy with montelukast may lead to improved sleep study findings in children
with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical
removal of adenoids and tonsils for OSAS.
- A significant proportion of the children with OSAS treated with montelukast will show
reduced severity of OSAS, and this will remove the need for surgical intervention.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Eligible for inclusion in the study will be symptomatic snoring children >2 years of
age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST
(hour total sleep time), and in whom T&A is therefore contemplated. Also among these,
we will include children referred for evaluation for snoring who have a history of
allergic rhinitis.
Exclusion Criteria:
- Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or
immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic
abnormalities, acute upper respiratory tract infection, systemic corticosteroid
therapy or antibiotic therapy in the 2 weeks previous to the study, and children who
already had adenotonsillectomy. In addition, children chronically receiving oral
antihistamine preparations or nasal decongestants will be required to continue using
these medications throughout the duration of the study. Patients receiving
immunotherapy will continue on the same regimen without escalation of dose and
frequency throughout the duration of the study. In addition, patients with severe OSA
who in the opinion of their treating physicians require early surgical intervention
for their OSA will be excluded from eligibility to the study.
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| NCT ID: |
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NCT01027806 |
| Primary Contact: |
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Principal Investigator
Leila Gozal, MD
University of Chicago
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637
United States
Leila K Gozal, MD
Phone: 773-834-3815
Email: lgozal@peds.bsd.uchicago.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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