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

NCT01574885 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-11-08

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Halotherapy

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.

DEVICE

Placebo

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 & Collaborators

  • Centro Studi Gised

    collaborator OTHER

  • Tecno Sun SRL

    lead INDUSTRY

Principal Investigators

  • Matteo Gelardi, MD · University General Hospital Consortium of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2013-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574885 on ClinicalTrials.gov