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| Name | Class |
|---|---|
| Centro Studi Gised | OTHER |
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The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosal | Experimental | This arm include all patients treated with Aerosal® |
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| Placebo | Placebo Comparator | This arm include all patients treated with placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halotherapy | Device | The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% | 2 weeks (10 sessions), 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks (10 sessions), 14 weeks |
| Any change from baseline of tympanometry curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matteo Gelardi, MD | University General Hospital Consortium of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital Consortium | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041858 | Derived | Gelardi M, Iannuzzi L, Greco Miani A, Cazzaniga S, Naldi L, De Luca C, Quaranta N. Double-blind placebo-controlled randomized clinical trial on the efficacy of Aerosal in the treatment of sub-obstructive adenotonsillar hypertrophy and related diseases. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1818-24. doi: 10.1016/j.ijporl.2013.08.013. Epub 2013 Aug 22. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Placebo | Device | The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes. |
|
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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 |
| 2 weeks (10 sessions), 14 weeks |
| Any change from baseline of adenotonsillar hypertrophy degree | 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 | 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 | 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 | 2 weeks (10 sessions), 14 weeks |
| Any change from baseline of hypoacusis | Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz) | 2 weeks (10 sessions), 14 weeks |
| Number of reported adverse events | Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it | 2 weeks (10 sessions), 14 weeks |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |