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Search / Trial NCT06630078

Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 28, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring the use of voice analysis, supported by artificial intelligence, to help diagnose and monitor various respiratory conditions in both children and adults. Conditions being studied include bronchiolitis, asthma, and certain cancers of the head and neck, especially in patients undergoing radiotherapy. The goal is to find a simple and non-invasive way to assess these health issues, making it easier for doctors to recognize problems early and tailor treatments to individual needs.

To participate in this study, children must be under 24 months with bronchiolitis, or aged 6-12 with asthma that is well-controlled or flaring up. Adults who may qualify include those with acute or chronic upper respiratory issues or those diagnosed with head and neck cancer receiving treatment. Participants can expect to provide voice samples and other health information, which will be analyzed to improve understanding and management of these respiratory conditions. It’s important to note that some individuals, like those with specific health issues or older adults over 70, will not be eligible to participate.

Gender

ALL

Eligibility criteria

  • INCLUSION CRITERIA:
  • Children with bronchiolitis \<24 months of age clinically characterized according to the clinical definition accepted by international literature (Ralstone);
  • Children with asthma according to most recent GINA guidance (Global Initiative for Asthma, 2022) aged 6-12 years in a phase of proper control or during acute exacerbations;
  • Adults with upper aerodigestive tract chronic or acute clinical conditions;
  • Adults with pathologic diagnosis of head and neck cancer addressed to radiotherapy with or without chemotherapy for primary treatment of the tumor.
  • EXCLUSION CRITERIA:
  • Children with comorbidities including genetic disorders;
  • Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);
  • Children with primary immunologic diseases;
  • Children with prematurity;
  • Children with other respiratory conditions not part of the inclusion criteria (examples: pneumonia, tonsillitis);
  • Adults over 70 years old or with neurological diseases;
  • Adults with syndromic disease;
  • Adults with malformations of upper aero-digestive tract;
  • Adults with history of head and neck surgery or not able to sustain a vocalism for more than 3 sec.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Jacopo Galli

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported