NCT05324696: OME

Autoinflation: Alternative in the Treatment of Otitis Media With Effusion

Status unknown NA Last updated 24 August 2022

What this trial tests

NA trial testing autoinflation device in Otitis Media With Effusion in 50 participants. Status unknown.

Timeline

1 November 2020

Primary endpoint
1 December 2022

3 December 2023

Quick facts

Lead sponsor	Instituto de Ciências Biomédicas Abel Salazar
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 November 2020
Primary completion	1 December 2022
Estimated completion	3 December 2023
Sites	1 location across Portugal

Drugs / interventions tested

• autoinflation device

Conditions studied

• Otitis Media With Effusion — all drugs for Otitis Media With Effusion →
• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Instituto de Ciências Biomédicas Abel Salazar

Who can join

Adults 3 to 8, any sex, with Otitis Media With Effusion or Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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;

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Autoinflation for otitis media with effusion (OME) in children.
   Webster KE, Mulvaney CA, Galbraith K, Rana M, et al · · 2023 · cited 9× · PMID 37750500 · DOI 10.1002/14651858.cd015253.pub2