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Trial Title:
Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions
NCT ID:
NCT06630078
Condition:
Airway Disease
Cancer of Head and Neck
Radiotherapy
Bronchiolitis
Asthma
Conditions: Official terms:
Bronchiolitis
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Wevosys acoustic analysis
Description:
Recording of voice signal of subjects enrolled
Arm group label:
Case group
Summary:
Acute and Chronic respiratory conditions represent a leading cause of death and morbidity
in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic
exacerbations is based on clinical, and mostly subjective, clinical parameters with
moderately accurate prognostic role. Patients undergoing neck radiotherapy need invasive
assessments of larynx. A simple biomarker like Voice may facilitate the management of
these conditions. Recent studies showed that VOICE may be used as a good and easy
biomarker to diagnose and monitor several respiratory and non-respiratory conditions. A
prospective study aimed to collected VOICE and other clinical data in adults and children
with common acute and chronic respiratory conditions at high impact on healthcare systems
will be performed. VOICE-omic data will be linked with clinical findings generating data
integration, using artificial intelligence technology to develop a Decision Support
Systems to provide the basis for non-invasive personalised early recognition, diagnosis,
monitoring and prognosis of patients with these conditions.
Criteria for 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.
Gender:
All
Minimum age:
12 Months
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jacopo Galli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Contact:
Last name:
Jacopo Galli
Phone:
+393338356370
Email:
jacopo.galli@policlinicogemelli.it
Investigator:
Last name:
Jacopo Galli
Email:
Principal Investigator
Facility:
Name:
Maria Raffaella Marchese
Address:
City:
Roma
Zip:
00198
Country:
Italy
Start date:
November 30, 2024
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630078
