OBJECTIVE: We tested the hypothesis that a 6-week course of a nasal glucocorticoid spray would decrease the severity of obstructive sleep apnea in children with adenotonsillar hypertrophy. STUDY DESIGN: We conducted a randomized, triple-blind, placebocontrolled, parallel-group trial of nasal fluticasone propionate versus placebo in 25 children aged 1 to 10 years with obstructive sleep apnea proven on polysomnography. The primary outcome was the change from baseline in the frequency of mixed and obstructive apneas and hypopneas. RESULTS:Thirteen children receivedfluticasone, and 12 received placebo. The mixed/obstructive apnea/hypopnea index decreased from 10.7 +/- 2.6 (SE) to 5.8 +/- 2.2 in the fluticasone group but increased from 10.9 +/- 2.3 to 13.1 +/- 3.6 in the placebo group, P =.04. The mixed/obstructive apnea/hypopnea index decreased in 12 of 13 subjects treated with fluticasone versus 6 of 12 treated with placebo, P =.03. The frequencies of hemoglobin desaturation and respiratory movement/arousals also decreased more in the fluticasone group. Changes from baseline in tonsillar size, adenoidal size, and symptom score were not significantly different between groups. CONCLUSION:Nasal fluticasone decreased the frequency of mixed and obstructive apneas and hypopneas, suggesting that topical corticosteroids may be helpful in ameliorating pediatric obstructive sleep apnea.
RCT Entities:
OBJECTIVE: We tested the hypothesis that a 6-week course of a nasal glucocorticoid spray would decrease the severity of obstructive sleep apnea in children with adenotonsillar hypertrophy. STUDY DESIGN: We conducted a randomized, triple-blind, placebocontrolled, parallel-group trial of nasal fluticasone propionate versus placebo in 25 children aged 1 to 10 years with obstructive sleep apnea proven on polysomnography. The primary outcome was the change from baseline in the frequency of mixed and obstructive apneas and hypopneas. RESULTS: Thirteen children received fluticasone, and 12 received placebo. The mixed/obstructive apnea/hypopnea index decreased from 10.7 +/- 2.6 (SE) to 5.8 +/- 2.2 in the fluticasone group but increased from 10.9 +/- 2.3 to 13.1 +/- 3.6 in the placebo group, P =.04. The mixed/obstructive apnea/hypopnea index decreased in 12 of 13 subjects treated with fluticasone versus 6 of 12 treated with placebo, P =.03. The frequencies of hemoglobin desaturation and respiratory movement/arousals also decreased more in the fluticasone group. Changes from baseline in tonsillar size, adenoidal size, and symptom score were not significantly different between groups. CONCLUSION: Nasal fluticasone decreased the frequency of mixed and obstructive apneas and hypopneas, suggesting that topical corticosteroids may be helpful in ameliorating pediatric obstructive sleep apnea.
Authors: V Tsara; A Amfilochiou; J M Papagrigorakis; D Georgopoulos; E Liolios; A Kadiths; E Koudoumnakis; E Aulonitou; M Emporiadou; M Tsakanikos; A Chatzis; M Choulakis; G Chrousos Journal: Hippokratia Date: 2010-01 Impact factor: 0.471