RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years to 17 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well the Medentum Diagnostik device and app identify asthma and ear, nose, and throat (ENT) problems in children. It compares diagnoses made by artificial intelligence (AI) with those made by clinicians. Children will use the device at home with online clinician visits or receive usual in-person care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 4–17 for the asthma group or 3–17 for the ear, nose, and throat group.
  • For the asthma group: Have ongoing asthma, from mild to severe, diagnosed using standard guidelines. In the past year, symptoms or flare-ups must have needed prednisone or albuterol for more than 24 hours during a sudden wheezing episode.
  • For the ear, nose, and throat group: Have had a common condition, such as a middle ear infection or strep throat, diagnosed using standard guidelines in the past year.
  • Have a smartphone, tablet, or other device that can run the study app, plus Wi-Fi or cell service.
  • Get routine care from the University of Arizona or its partner clinics in Arizona, and have active health insurance.
  • Have permission from a parent or guardian. Children ages 7 and older must also agree to join.

Who can't join

  • Have another long-term lung disease, such as cystic fibrosis, that needs complex specialist care.
  • Have cerebral palsy, a condition affecting brain development, or a heart problem present at birth.
  • Have a complex long-term health condition or ongoing ear, nose, or throat problems that need complex specialist care.
  • Have had ear tubes placed or surgery to remove the tonsils or adenoids.
  • Have ongoing middle ear problems with pus or fluid buildup.
  • Have had a severe asthma flare-up needing a hospital stay or intensive treatment in the past 4 weeks.
  • Have speech delays, hearing loss, or problems with thinking or learning that could affect correct use of the device.
  • The child or family cannot follow study instructions, attend follow-up visits, or use the device correctly.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

AZ