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RECRUITING

NCT07500532

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

Sponsor: Medentum Innovations

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-10-01

Completion Date

2026-12-01

Last Updated

2026-03-30

Healthy Volunteers

Yes

Conditions

Acute Otitis Media (AOM)Strep Pharyngitis Asthma Exacerbation Pediatric Asthma

Interventions

DEVICE

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 wheeze/asthma exacerbation

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.

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.

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.

Locations (1)

El Rio Health System

Tuscon, Arizona, United States