CompletedPhase 4

Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

Italy45 participantsStarted 2009-01

Plain-language 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 apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.

Who can participate

Age range2 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:

Timeframe: 1 year

Trial details

NCT IDNCT00912171

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

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