Sleep Apnea, Obstructive
Conditions
Keywords
sleep apnea, adenotonsillar hypertrophy, salt, sodium chloride
Brief summary
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.
Interventions
DEVICEHalotherapy
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.
DEVICEPlacebo
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.
Sponsors
Centro Studi Gised
Tecno Sun SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% | 2 weeks (10 sessions), 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any change from baseline of tympanometry curve | 2 weeks (10 sessions), 14 weeks | 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 |
| Any change from baseline of adenotonsillar hypertrophy degree | 2 weeks (10 sessions), 14 weeks | — |
| Any change from baseline of basal SpO2% levels | 2 weeks (10 sessions), 14 weeks | Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry |
| Change from baseline of hypoacusis equal to or greater than 10 dB | 2 weeks (10 sessions), 14 weeks | 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) |
| Any change from baseline of sleep time percentage with SpO2<95% | 2 weeks (10 sessions), 14 weeks | Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry |
| Any change from baseline of hypoacusis | 2 weeks (10 sessions), 14 weeks | Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz) |
| Number of reported adverse events | 2 weeks (10 sessions), 14 weeks | Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it |
| Any change from baseline of apnea index | 2 weeks (10 sessions), 14 weeks | Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry |
Countries
Italy
Outcome results
None listed