Home Medentum Diagnostik device for children with asthma and ear and throat problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls children with asthma or recent ENT conditions and follows them for six months. Participants are randomized to home use of the Medentum Diagnostik platform (multifunction device plus smartphone app and AI, with telehealth clinician support) or to standard-of-care in-person or telehealth evaluation without the device. During symptomatic episodes intervention participants record lung sounds, capture ear/throat images, enter symptoms, and collect vitals; clinicians review device data during telehealth visits. Primary outcomes compare agreement between AI-generated diagnoses and clinician diagnoses; secondary outcomes include agreement with independent research diagnoses, usability, satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution.

Why it matters

Who can join: the full rules

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.

Where it's running

• El Rio Health System
  Tuscon, Arizona, United States Recruiting

Study contacts

• Study coordinator: Starla Kiser, Medical Degree
• Email: starla@medentum.com
• Phone: 276-212-1863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.