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Autoinflation: Alternative in the Treatment of Otitis Media With Effusion

NCT05324696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-24

No results posted yet for this study

Summary

Otitis media with effusion (OME) is a common finding affecting children and the main cause of acquired hearing loss in the pediatric age.

OBJECTIVES

The purpose of the clinical study is to determine whether self-inflation using a new device:

* It is an effective non-invasive treatment during the watchful waiting period, with the ability to improve hearing loss and prevent surgical treatment;
* Maintains long-term hearing improvement;

Conditions

Interventions

DEVICE

autoinflation device

The authors developed a new standardized, inexpensive and simple device, based on Moniri. The Device is formed by a T tube with a unidirectional valve. A mask with the capacity of covering the child's mouth and nose, providing hermetic seal, and a balloon are connected to 2 ends of the T tube. Blowing the balloon trough the mask, with different types of maneuvers, will force the opening of the Eustachian tube and subsequent reabsorption of the middle ear effusion.

Sponsors & Collaborators

  • Instituto de Ciências Biomédicas Abel Salazar

    lead OTHER

Principal Investigators

  • João Lino, MD · Instituto de Ciências Biomédicas Abel Salazar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-01
Completion
2023-12-03

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

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 NCT05324696 on ClinicalTrials.gov