Status:
COMPLETED
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children
Lead Sponsor:
University of Bologna
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
2-10 years
Phase:
PHASE4
Brief Summary
The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apne...
Detailed Description
The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if ...
Eligibility Criteria
Inclusion
- Diagnosis of mild (RDI 3- \<5) or moderate obstructive apneas (RDI 5-8) by overnight polysomnographic evaluation with 4 channels EEG
- Adenotonsillar hypertrophy Friedman score's II-III-IV°
Exclusion
- Neuromuscular, gastrointestinal, neurological diseases and syndromes of malformations
- Use of leukotrienes and/or nasal and oral steroids in the 4 weeks preceding the initial sleep study
- Acute upper respiratory tract infections
- Adenotonsillectomy
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00912171
Start Date
January 1 2009
End Date
June 1 2010
Last Update
February 15 2013
Active Locations (1)
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1
Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna
Bologna, Italy, 40138