Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

Change from baseline of hypoacusis equal to or greater than 10 dB

Change from baseline of hypoacusis equal to or greater than 10 dB, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of tympanometry curve

Any change from baseline of tympanometry, defined as the passage from curve type B to curve type C/A or from curve type C to curve type A

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of adenotonsillar hypertrophy degree

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of basal SpO2% levels

Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of apnea index

Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of sleep time percentage with SpO2<95%

Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry

Time frame: 2 weeks (10 sessions), 14 weeks

Any change from baseline of hypoacusis