Health TrialsbyHealthPanel

Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

ConditionsAcute Otitis Media (AOM)Strep PharyngitisAsthma ExacerbationPediatric Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorMedentum Innovations

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: Patients between the ages of 4 and 17 years (asthma) and 3-17 years (ENT)

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis

    Device

    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

    Device

    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

    Other intervention

    * 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 Group

    Other intervention

    * 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.

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platformExperimental treatment 1 intervention
Group B: Moderate-to-severe pediatric asthma patients using standard-of-care asthma managementPlacebo comparator 1 intervention
Group C: Pediatric ENT patients with standard-of-care ENT managementPlacebo comparator 1 intervention
Group D: Pediatric ENT patients with home-based use of Diagnostik platformExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

El Rio Health SystemRecruiting85745, Tuscon, ArizonaUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medentum Innovations

Lead sponsor

University of Arizona

Collaborator

National Institutes of Health (NIH)

Collaborator

El Rio Community Health Center

Collaborator

Source ClinicalTrials.gov
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