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

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Halotherapy
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sub-Obstructive Adenotonsillar Hypertrophy lasting from at least six months and associated with sleep disordered breathing (respiratory pauses or sleep-apnea) and/or recurrent sero-mucus otitis Suspension for more than 3 months from the date of any immunosuppressive treatments (cyclosporin, systemic steroids) Exclusion Criteria: Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma. Iodine allergy

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosal<br>This arm include all patients treated with Aerosal® | Device: Halotherapy<br>* 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.<br>* Other names: sodium chloride;|
| Placebo Comparator: Placebo<br>This arm include all patients treated with placebo | Device: Placebo<br>* 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.<br>* Other names: comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% |  | 2 weeks (10 sessions), 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, adenotonsillar hypertrophy, salt, sodium chloride