Clinical trial NCT06630078: Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions
Official title: Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Disease
Cancer of Head and Neck
Radiotherapy
Bronchiolitis
Asthma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


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.

Primary outcomes:
measure: Acoustic parameters of voice signal in children
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in children
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in children
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in children
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
timeFrame: enrollment; 24 and 48 hours post-therapy; 24 months
measure: Pediatric Dyspnea Scale
timeFrame: enrollment; 24 hours and 48 hours post-therapy; 24 months
measure: Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases
timeFrame: enrollment; 24 hours and 48 hours after therapy; 24 months
measure: Acoustic parameters of voice signal in adults underwent radiotherapy
timeFrame: enrollment; on the 30th day of radiotherapy
measure: Acoustic parameters of voice signal in adults underwent radiotherapy
timeFrame: enrollment; on the 30th day of radiotherapy
measure: Acoustic parameters of voice signal in adults underwent radiotherapy
timeFrame: enrollment; on the 30th day of radiotherapy
measure: Acoustic parameters of voice signal in adults underwent radiotherapy
timeFrame: enrollment; on the 30th day of radiotherapy
measure: Voice Handicap Index score in adults who underwent radiotherapy
timeFrame: enrollment; on the 30th day of radiotherapy
measure: Dysphagia Handicap Index in adults who underwent radiotherapy
timeFrame: enrollmentt; on the 30th day of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Jacopo Galli
city: Roma
country: Italy
facility: Maria Raffaella Marchese
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Jacopo Galli
role: PRINCIPAL_INVESTIGATOR
References: