Autoinflation: Alternative in the Treatment of Otitis Media With Effusion

NCT05324696 | Unknown DMC

• 1 other identifier: 052-DEFI/ 053-CE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Otitis Media With Effusion; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram)

  Outcomes assessed by sustained improvement in the audiological study carried out with the following complementary diagnostic tests: audiogram and tympanogram

  3 years

Study Arms (3)

Treatment with placebo device

PLACEBO COMPARATOR

Device similar to the one developed, but which does not generate pressure

Device: autoinflation device

Treatment with a working device

EXPERIMENTAL

Treatment with a functioning device, which generates the necessary pressure to open the Eustachian tube

Device: autoinflation device

Surgical treatment

ACTIVE COMPARATOR

Surgical treatment (myringotomy with placement of ventilation tubes) which is the treatment currently applied in children with otitis media with effusion that do not resolve with medical treatment and/or autoinflation

Device: autoinflation device

Interventions

autoinflation device 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.

Surgical treatment; Treatment with a working device; Treatment with placebo device

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Instituto de Ciências Biomédicas Abel Salazar: lead

Study Sites (1)

Centro Hospitalar Univrsitário do Porto

Porto, 4099-001, Portugal

RECRUITING

MeSH Terms

Conditions

Otitis Media with Effusion; Hearing Loss

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• João Lino, MD

  Instituto de Ciências Biomédicas Abel Salazar

  STUDY DIRECTOR

Central Study Contacts

João Lino, MD

CONTACT

+351919374568; joaovalelino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 12, 2022
• Study Start: November 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 3, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)