Obstructive Sleep Apnea Syndrome
Conditions
Keywords
obstructive sleep apnea syndrome, snoring, adenotonsillar hypertrophy, polysomnography, intranasal steroids, Anti-leukotrienes
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 apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.
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 leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.
Interventions
DRUGbudesonide (Aircort 50 nasal spray)
50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months
Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment: | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical upper airway patency during the night in the patients with history of allergic rhinitis compared with the patients without history of allergic rhinitis first and after the treatment for OSAS | 1 year |
Countries
Italy
Outcome results
None listed