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Autoinflation: Alternative in the Treatment of Otitis Media With Effusion (OME)

Primary Purpose

Otitis Media With Effusion, Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
autoinflation device
Sponsored by
Instituto de Ciências Biomédicas Abel Salazar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effusion

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

- Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist.

- Exclusion criteria: Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery.

Sites / Locations

  • Centro Hospitalar Univrsitário do PortoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Treatment with placebo device

Treatment with a working device

Surgical treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2022
Last Updated
August 22, 2022
Sponsor
Instituto de Ciências Biomédicas Abel Salazar
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1. Study Identification

Unique Protocol Identification Number
NCT05324696
Brief Title
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
Acronym
OME
Official Title
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Ciências Biomédicas Abel Salazar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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;
Detailed Description
Introduction Otitis media with effusion (OME) is a common finding affecting children in the age of 2-6 years. Although OME is the main cause of acquired hearing loss in the pediatric age, it's treatment it's still controversial. Due to high spontaneous resolution, current international guidelines recommend a period of "watchful waiting" for 3 to 6 months after which, if the hearing loss persists, surgery with tympanostomy tube insertion under general anesthesia is indicated. During the watchful waiting period, medical treatment options, such as oral and nasal corticosteroids, antibiotics, mucolytics or nasal decongestants, are not recommended due to lack of effect or side effects. Nevertheless, the results of autoinflation in the treatment of OME in children are divergent although suggestive of clinical effect in the short-term. In a previous study the authors concluded that autoinflation with a new device - Moniri® Medical Device - resolved the OME and prevented surgery in 80% of children with chronic OME. In this study, the authors developed a new standardized, inexpensive and simple device, based on Moniri® Medical Device. 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. Aime Our aim it's to prove that autoinflation is an efficient non-invasive treatment during the watchful waiting period, with the capacity of improving hearing loss thus preventing surgical treatment. Material and Methods Study design: Clinical investigation, prospective, blinded and randomized. Sample: Children between 3 and 8 years of age - Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist. - Exclusion criteria: Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery. - Recruitment: Children followed up at the Otorhinolaryngology outpatient clinic at Centro Hospitalar do Porto with a diagnosis of OME, who are in watchful waiting period. Parents/legal guardians of children who meet the inclusion criteria are invited to participate. - Study groups Blindly and randomly, three study groups are created: > GROUP A: Treatment with placebo device > GROUP B: Treatment with a functioning device The Device to be studied results from the combination of different components, all of them used in different medical areas and all of them individually already approved by the National Authority for Medicines and Health Products. After an exposure to two expertises of the National Authority for Medicines and Health Products in the field of medical devices, the researchers were informed that the use of the combination of the various components should be considered an off-label use of the same and, as such, does not require formal requirement for approval of use. > GROUP C: Surgical treatment. Children undergoing surgical treatment for OME (myringotomy with placement of transtympanic ventilation tubes +/- adenoidectomy), as they have already exceeded the period of "watchful waiting" and who had a surgical indication, will be included in group C. This group, representative of the current treatment recommended in cases of persistent OME, will serve to compare results with the proposed new treatment. Study groups will be evaluated at 1, 3, 6, 12 and 18 months after treatment initiation (placebo device, functioning device or surgery). Children will undergo audiological assessment with otomicroscopy, tympanogram and audiogram. The results will be compared in the same child, to evaluate if there was resolution of OME, and between groups to evaluate the effectiveness of the treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion, Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with placebo device
Arm Type
Placebo Comparator
Arm Description
Device similar to the one developed, but which does not generate pressure
Arm Title
Treatment with a working device
Arm Type
Experimental
Arm Description
Treatment with a functioning device, which generates the necessary pressure to open the Eustachian tube
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
autoinflation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram)
Description
Outcomes assessed by sustained improvement in the audiological study carried out with the following complementary diagnostic tests: audiogram and tympanogram
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
- Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist. - Exclusion criteria: Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João Lino, MD
Phone
+351919374568
Email
joaovalelino@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Lino, MD
Organizational Affiliation
Instituto de Ciências Biomédicas Abel Salazar
Official's Role
Study Director
Facility Information:
Facility Name
Centro Hospitalar Univrsitário do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Lino, MD
Phone
+351919374568
Email
joaovalelino@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Autoinflation: Alternative in the Treatment of Otitis Media With Effusion

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