Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions (AIRWAY-VDAP)

Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Bronchiolitis; Cancer of Head and Neck; Radiotherapy; Airway Disease
• Intervention / Treatment: Device: Wevosys acoustic analysis

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacopo Galli; Phone Number: +393338356370; Email: jacopo.galli@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Jacopo Galli
    • Contact: Jacopo Galli; Phone Number: +393338356370; Email: jacopo.galli@policlinicogemelli.it
    • Principal Investigator: Jacopo Galli
  • Roma, Italy, 00198
    • Maria Raffaella Marchese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; children with bronchiolits, controlled asthma and asthmatic re-exacerbations and adults with primary upper aero-digestive tract affections or secondary to radiotherapy	Device: Wevosys acoustic analysis; Recording of voice signal of subjects enrolled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acoustic parameters of voice signal in children	Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in children	Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in children	Shimmer (%) relates to the amplitude variation of the sound wave.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases	Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases	Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle; Shimmer (%) relates to the amplitude variation of the sound wave.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases	Shimmer (%) relates to the amplitude variation of the sound wave.	enrollment; 24 and 48 hours post-therapy; 24 months
Pediatric Dyspnea Scale	The child is asked to answer the question "How much difficulty are you having breathing?" by choosing the column that best corresponds to his or her perceived symptoms (range from 0 not trouble at all to 7 very much trouble)	enrollment; 24 hours and 48 hours post-therapy; 24 months
Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases	The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)	enrollment; 24 hours and 48 hours after therapy; 24 months
Acoustic parameters of voice signal in adults underwent radiotherapy	Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.	enrollment; on the 30th day of radiotherapy
Acoustic parameters of voice signal in adults underwent radiotherapy	Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.	enrollment; on the 30th day of radiotherapy
Acoustic parameters of voice signal in adults underwent radiotherapy	Shimmer (%) relates to the amplitude variation of the sound wave.	enrollment; on the 30th day of radiotherapy
Voice Handicap Index score in adults who underwent radiotherapy	The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)	enrollment; on the 30th day of radiotherapy
Dysphagia Handicap Index in adults who underwent radiotherapy	The Dysphagia Handicap Index is a 25-item measure of Health-related Quality of Life for patients with oropharyngeal dysphagia of heterogeneous etiologies. The total score ranges from 0 to 100, with lower scores indicating better swallowing-related QoL.	enrollmentt; on the 30th day of radiotherapy
Acoustic parameters of voice signal in children	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.	enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults underwent radiotherapy	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.	enrollment; on the 30th day of radiotherapy

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Jacopo Galli, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Head and Neck Neoplasms; Bronchiolitis
• Other Study ID Numbers: ID6812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No