Clinical trial NCT00912171: Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children
Official title: Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: obstructive sleep apnea syndrome
snoring
adenotonsillar hypertrophy
polysomnography
intranasal steroids
Anti-leukotrienes
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment:
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna
Study officials:
affiliation: University of Bologna
name: Filippo Bernardi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gozal D, Crabtree VM, Sans Capdevila O, Witcher LA, Kheirandish-Gozal L. C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children. Am J Respir Crit Care Med. 2007 Jul 15;176(2):188-93. doi: 10.1164/rccm.200610-1519OC. Epub 2007 Mar 30.
citation: Goldbart AD, Krishna J, Li RC, Serpero LD, Gozal D. Inflammatory mediators in exhaled breath condensate of children with obstructive sleep apnea syndrome. Chest. 2006 Jul;130(1):143-8. doi: 10.1378/chest.130.1.143.
citation: Gozal D, Kheirandish-Gozal L. Sleep apnea in children--treatment considerations. Paediatr Respir Rev. 2006;7 Suppl 1:S58-61. doi: 10.1016/j.prrv.2006.04.174. Epub 2006 Jun 5.
citation: Kheirandish L, Goldbart AD, Gozal D. Intranasal steroids and oral leukotriene modifier therapy in residual sleep-disordered breathing after tonsillectomy and adenoidectomy in children. Pediatrics. 2006 Jan;117(1):e61-6. doi: 10.1542/peds.2005-0795.
citation: Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. doi: 10.1164/rccm.200408-1064OC. Epub 2005 May 5.