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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma Exacerbation; Pediatric Asthma; Acute Otitis Media (AOM); Strep Pharyngitis
• Intervention / Treatment: Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation; Other: Routine Asthma Management (in-person and telehealth visits)- Control Group; Other: Routine ENT Management (in-person and telehealth visits)- Control Group; Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis

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:

1. home-based use of the Diagnostik platform with telehealth-supported clinician evaluation (intervention arm), or
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Starla Kiser, Medical Degree; Phone Number: 276-212-1863; Email: starla@medentum.com

Study Locations

• United States
  • Arizona
    • Tuscon, Arizona, United States, 85745
      • Recruiting
      • El Rio Health System
      • Contact: Erin Dougherty, Masters Degree; Phone Number: 520-670-3909; Email: ErinD@elrio.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platform; 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	Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation; Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
Placebo Comparator: Moderate-to-severe pediatric asthma patients using standard-of-care asthma management; Control Group receiving in-office standard of care for routine well visits, and urgent care/ED visits as needed. No Diagnostik platform use.	Other: Routine Asthma Management (in-person and telehealth visits)- Control Group; 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.
Placebo Comparator: Pediatric ENT patients with standard-of-care ENT management; Control Group receiving in-office standard of care for routine well visits, and routine care, urgent care/ED visits as needed.	Other: Routine ENT Management (in-person and telehealth visits)- Control Group; 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.
Experimental: Pediatric ENT patients with home-based use of Diagnostik platform; 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	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 AOM and strep pharyngitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months
Asthma Control Test Score	Team will assess Asthma Control Test (ACT) standardized scores between the two groups	6 months
Symptom Days	The team will measure the number of days of asthma/ENT symptoms between the two groups.	6 months
Frequency of Rescue Inhaler Use	The team will measure the frequency of rescue inhaler use between the control and intervention asthma groups.	6 months

Collaborators and Investigators

• Sponsor: Medentum Innovations
• Collaborators: National Institutes of Health (NIH); University of Arizona; El Rio Community Health Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: Medentum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No