Acute Otitis Media (AOM)NCT07500532
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
A study testing Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis and Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation in people with Acute Otitis Media (AOM) and Strep Pharyngitis, run by Medentum Innovations at 1 site in United States.
Trial summary
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media (AOM), Strep Pharyngitis, Asthma Exacerbation
- What is being tested?
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis and Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: Patients between the ages of 4 and 17 years (asthma) and 3-17 years (ENT)
- Diagnosis:
- o Asthma patients: Diagnosed with mild-to-moderate and severe persistent asthma according to Global Initiative for Asthma (GINA) guidelines, with a history of symptoms or exacerbations requiring medical intervention (prior prednisone course and/or albuterol for >24 hours in context of acute wheezing episode) in the past 12 months. ENT patients: Diagnosed with common ENT conditions such as acute otitis media (AOM) or strep pharyngitis in the prior year. Diagnosis must be based on established clinical guidelines.
- Technology access: Must have access to a smartphone, tablet, or other device capable of running the Medentum Diagnostik platform app and access to Wifi or cellular service.
- Care access: Must be receiving routine care from University of Arizona or associated clinics in Arizona and have active health insurance
- Consent: Must have parental or guardian consent for participation, as well as child assent when appropriate.(all children ≥7 yrs)
Who cannot join
- Other medical conditions: Patients with additional chronic lung diseases (such as cystic fibrosis) requiring complex specialist care will be excluded. cerebral palsy, neurodevelopmental conditions, congenital heart disease. Patients with complex chronic conditions or chronic ENT conditions requiring complex specialist care will be excluded.
- Recent surgical/complex ENT medical history: Patients who have had tympanostomy tubes or tonsillectomy/adenoidectomy, patients with chronic ENT conditions including chronic suppurative or serous otitis media
- Recent medical history: Patients who have experienced severe asthma exacerbations requiring hospitalization or intensive treatment in the past 4 weeks
- Comorbidities: Patients with speech delays, hearing impairments, or cognitive impairments that may affect their ability to use the Diagnostik platform accurately will be excluded.
- Non-compliance risk: Patients or families that are unable to follow study instructions, comply with follow-up visits, or properly use the Medentum platform will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
El Rio Health System
Tuscon, Arizona, 85745
Erin Dougherty, Masters Degree, 520-670-3909, ErinD@elrio.org
About this study
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care.
The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters, including telehealth evaluations in the Diagnostik arm and in-person evaluations in the standard-of-care arm. Secondary objectives include evaluating agreement between AI-generated diagnoses and independent research team diagnoses, as well as assessing usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution.
This study will also evaluate differences in healthcare utilization, including in-person visits, emergency care use, and time to diagnosis and treatment, between study groups.
Read the detailed description
Study Design and Methodology
This study is a randomized, controlled clinical trial designed to evaluate the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform in pediatric patients with asthma and ear, nose, and throat (ENT) conditions, including acute otitis media and pharyngitis .
Participants will be randomized to one of two groups:
- home-based use of the Diagnostik platform with telehealth-supported clinician evaluation (intervention arm), or
- standard-of-care clinical evaluation via in-person or telehealth visits without use of the Diagnostik platform (control arm).
The study duration is 6 months. Intervention participants will use the Diagnostik platform during symptomatic episodes and for monthly monitoring (asthma patients), while control participants will receive routine clinical care. Follow-up data will be collected through platform data, medical record review, and patient-reported outcomes.
Intervention and Data Collection
Participants in the intervention arm will use the Diagnostik platform, which integrates a smartphone application with a multifunctional medical device, including a digital stethoscope, otoscope, thermometer, and pulse oximeter, to collect clinical data at home .
During symptomatic episodes, participants will:
Record lung sounds using the digital stethoscope Capture images of the ear or throat Enter symptom data and complete relevant questionnaires (e.g., Asthma Control Test) Measure vital signs, including temperature, heart rate, and oxygen saturation
The platform's AI algorithms will analyze these data to generate a preliminary diagnostic assessment (e.g., presence or absence of wheeze, acute otitis media, pharyngitis). Intervention participants will then undergo a telehealth consultation with a clinician who will review the collected data, consider the AI-generated assessment, and establish a clinical diagnosis.
Participants in the control arm will receive standard clinical care, including in-person or telehealth evaluations, during which clinicians will make diagnoses based on routine clinical assessment and testing.
Primary Outcome Assessment
The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters. Clinician diagnoses will be established via telehealth evaluation in the intervention arm and via standard-of-care evaluation (in-person or telehealth) in the control arm.
Diagnostic agreement will be evaluated separately for asthma and ENT conditions. Lung sounds will be assessed for the presence or absence of wheeze, and ear/throat images will be evaluated for acute otitis media and pharyngitis. Agreement between AI and clinician diagnoses will be quantified using percent agreement and Cohen's kappa.
Secondary and Exploratory Assessments
Secondary analyses will include evaluation of agreement between AI-generated diagnoses and research team diagnoses. Research diagnoses will be established by independent clinicians, including pediatric pulmonologists, based on blinded review of lung sound recordings and ear/throat images collected using the Diagnostik platform.
Additional secondary outcomes will include usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as symptom days, asthma control, rescue inhaler use, and time to symptom resolution. Healthcare utilization measures will include in-person visits, emergency department visits, and time to diagnosis and treatment.
Exploratory analyses will assess the performance of the AI system across clinical conditions and care settings.
- Being tested
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis, Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation, Routine Asthma Management (in-person and telehealth visits)- Control Group, Routine ENT Management (in-person and telehealth visits)- Control Group
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitisDevice
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbationDevice
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
Routine Asthma Management (in-person and telehealth visits)- Control GroupOther
- Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits.
- Patients in the control group will visit the clinic whenever they experience symptoms related to their asthma condition or any other non-respiratory, non-ENT medical condition.
- Telehealth visits will be offered as per routine and determined by the medical provider.
- Asthma patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments.
- Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.
Routine ENT Management (in-person and telehealth visits)- Control GroupOther
- Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits.
- Patients in the control group will visit the clinic whenever they experience symptoms related to their ENT condition or any other non-respiratory, non-ENT medical condition.
- Telehealth visits will be offered as per routine and determined by the medical provider.
- ENT patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments.
- Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platform | Experimental | Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform (multisensor device, + app+ AI platform) for telehealth management of asthma Receives: Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation |
| Moderate-to-severe pediatric asthma patients using standard-of-care asthma management | Placebo comparator | Control Group receiving in-office standard of care for routine well visits, and urgent care/ED visits as needed. No Diagnostik platform use. Receives: Other: Routine Asthma Management (in-person and telehealth visits)- Control Group |
| Pediatric ENT patients with standard-of-care ENT management | Placebo comparator | Control Group receiving in-office standard of care for routine well visits, and routine care, urgent care/ED visits as needed. Receives: Other: Routine ENT Management (in-person and telehealth visits)- Control Group |
| Pediatric ENT patients with home-based use of Diagnostik platform | Experimental | Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform for telehealth for ENT conditions Receives: Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic concordance between AI and physician/clinician
Arms and Interventions: Participants will be randomized to (1) home-based use of the Diagnostik device with telehealth-supported clinician evaluation or (2) in-clinic standard-of-care evaluation.
Primary Outcome: Agreement between AI-generated diagnosis and clinician diagnosis obtained during the study encounter. Clinician diagnosis will be determined via telehealth evaluation in the Diagnostik arm and in-person standard-of-care evaluation in the control arm. Participants will use the Diagnostik device to collect lung auscultation recordings via digital stethoscope and capture ear or throat images. AI algorithms will assess lung sounds for presence or absence of wheeze and images for acute otitis media and pharyngitis. Clinicians will establish diagnoses based on their respective evaluation modality. Agreement between AI and clinician diagnoses will be assessed separately for asthma and ENT conditions using percent agreement and Cohen's kappa. A concordance rate ≥85% is anticipated.
Measured: 6 months
Secondary outcomes (7)
Agreement between AI-generated diagnosis and research team diagnosis.
The research diagnosis will be established by an independent panel of clinicians, including pediatric pulmonologists, based on blinded review of lung sound recordings and ear/throat images collected using the Diagnostik device. Agreement will be assessed separately for asthma and ENT conditions using percent agreement and Cohen's kappa. Sensitivity and specificity may also be calculated.
Measured: 6 months
Usability: Net Promoter Score
Usability assessed using standardized questionnaires evaluating ease of use, patient satisfaction, Net Promoter Score (NPS), and technical difficulties encountered during platform use. NPS is scored from 0 to 100, with higher scores indicating greater user satisfaction. Questionnaires will be administered at 3 and 6 months. Additional measures will include convenience-related outcomes such as time from symptom onset to diagnosis and treatment, distance traveled, and wait times. We anticipate NPS of >70.
Measured: 6 months
Emergency Room Visit
Utilization outcome: Compare emergency room visit for ENT or asthma condition between the control standard of care, and at-home Diagnostik groups.
Measured: 6 months
Unscheduled medical visit for asthma or ENT condition
Healthcare utilization measured as the number of unscheduled in-person visits for asthma or ENT symptoms, including urgent care and emergency room visits, compared between study groups. Additional measures include symptom days, asthma control days, time to symptom resolution, rescue inhaler use, Asthma Control Test (ACT) scores, and complication rates.
Measured: 6 months
Asthma Control Test Score
Team will assess Asthma Control Test (ACT) standardized scores between the two groups
Measured: 6 months
Symptom Days
The team will measure the number of days of asthma/ENT symptoms between the two groups.
Measured: 6 months
Frequency of Rescue Inhaler Use
The team will measure the frequency of rescue inhaler use between the control and intervention asthma groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis Media (AOM)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 42 asthma patients: 21control (standard care), 21 intervention (use Diagnostik platform at home) * 42 ENT patients: 21 control (standard care), 21 intervention (use Diagnostik platform at home)
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medentum Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona, National Institutes of Health (NIH), El Rio Community Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500532
- Sponsor's protocol ID
- Medentum
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided