Otitis Media, SuppurativeOMA-IANCT04752891
Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department
A study testing AOM diagnosis with app and AOM diagnosis without app in people with Otitis Media, Suppurative, run by Fondation Lenval at 1 site in France.
Trial summary
Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Otitis Media, Suppurative
- What is being tested?
- AOM diagnosis with app and AOM diagnosis without app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 16 Mar 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained
Who cannot join
- A sign (s) of vital distress Trans-tympanic drains
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department
Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis
Read the detailed description
Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.
Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).
Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app
- Conditions
- Otitis Media, Suppurative
- Being tested
- AOM diagnosis with app, AOM diagnosis without app
- Medical subject headings
- Otitis Media, Suppurative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOM diagnosis with appOther
the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone
AOM diagnosis without appOther
the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope
| Study group | Role | What they receive |
|---|---|---|
| AOM diagnosis with app | Experimental | Not described Receives: Other: AOM diagnosis with app |
| AOM diagnosis without app | Other | Not described Receives: Other: AOM diagnosis without app |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle).
Measured: at inclusion
diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle)
Measured: at inclusion
Secondary outcomes (3)
rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application
a misdiagnosis is measured by a discordant diagnosis of the juniors compared to the seniors considered as the Gold Standard for the AOM diagnosis
Measured: at inclusion
collection risk factors for a discrepancy in the diagnosis of purulent AOM
collection data of age of patients,pain requiring analgesia, period of the day of diagnosis (morning, afternoon,night)
Measured: at inclusion
satisfaction of junior physicians regarding the use of the app
a questionnaire will be given at the end of the study. The questions relate to the use of the application and its perceived usefulness by practitioners. Satisfaction will be assessed by a Lickert scale
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start10 Jun 2021
- Primary completion16 Aug 2022
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media, SuppurativeStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752891
- Sponsor's protocol ID
- 20-HPNCL-07
- Acronym
- OMA-IA
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT04752891
- Acronym / sponsor ID
- OMA-IA / 20-HPNCL-07
- Conditions
- Otitis Media, Suppurative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 12 Feb 2021 (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 (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis
Detailed description
Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.
Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).
Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOM diagnosis with app | Experimental | Other: AOM diagnosis with app |
| AOM diagnosis without app | Other | Other: AOM diagnosis without app |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained
Key exclusion criteria (2 listed)
- A sign (s) of vital distress Trans-tympanic drains
- -
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 |
|---|---|---|
| AOM diagnosis with appthe diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone | Other | AOM diagnosis with app |
| AOM diagnosis without appthe diagnosis made by a senior physician and by the junior physician, using a traditional otoscope | Other | AOM diagnosis without app |
Primary outcome
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
Time frame: at inclusion
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle).
diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope
Time frame: at inclusion
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle)
3 secondary outcomes
rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application
Time frame: at inclusion
collection risk factors for a discrepancy in the diagnosis of purulent AOM
Time frame: at inclusion
satisfaction of junior physicians regarding the use of the app
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOM diagnosis with app and AOM diagnosis without app in people with Otitis Media, Suppurative, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Mar 2023. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope® (time frame: at inclusion). The study lists 2 primary outcomes in all. 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 17 Mar 2023.