Otitis Media With EffusionOMENCT05324696
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
A study testing autoinflation device in people with Otitis Media With Effusion and Hearing Loss, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media With Effusion, Hearing Loss
- What is being tested?
- autoinflation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2020to 3 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Univrsitário do Porto
Porto, 4099-001
João Lino, MD, +351919374568, joaovalelino@gmail.com
About this study
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;
Read the 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.
- Conditions
- Otitis Media With Effusion, Hearing Loss
- Being tested
- autoinflation device
- Medical subject headings
- Otitis Media with Effusion, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoinflation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with placebo device | Placebo comparator | Device similar to the one developed, but which does not generate pressure Receives: Device: autoinflation device |
| Treatment with a working device | Experimental | Treatment with a functioning device, which generates the necessary pressure to open the Eustachian tube Receives: 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 Receives: Device: autoinflation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Nov 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion3 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciências Biomédicas Abel Salazar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Lino, Instituto de Ciências Biomédicas Abel Salazar
- Investigators
- João Lino, MD, Study director, Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324696
- Sponsor's protocol ID
- 052-DEFI/ 053-CE
- Acronym
- OME
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
- ClinicalTrials.gov ID
- NCT05324696
- Acronym / sponsor ID
- OME / 052-DEFI/ 053-CE
- Conditions
- Otitis Media With Effusion, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Ciências Biomédicas Abel SalazarUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 3 Dec 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment with placebo device | Placebo comparator | Device: autoinflation deviceDevice similar to the one developed, but which does not generate pressure |
| Treatment with a working device | Experimental | Device: autoinflation deviceTreatment with a functioning device, which generates the necessary pressure to open the Eustachian tube |
| Surgical treatment | Active comparator | Device: autoinflation deviceSurgical 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 |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autoinflation deviceThe 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. | Device | Surgical treatment, Treatment with a working device, Treatment with placebo device |
Primary outcome
Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram)
Time frame: 3 years
Outcomes assessed by sustained improvement in the audiological study carried out with the following complementary diagnostic tests: audiogram and tympanogram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Lino, MD study director
Instituto de Ciências Biomédicas Abel Salazar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoinflation device in people with Otitis Media With Effusion and Hearing Loss, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Lino, MD (+351919374568, joaovalelino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.