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

Not Applicable

Not yet recruiting

• Conditions: Airway Disease; Cancer of Head and Neck; Radiotherapy; Bronchiolitis; Asthma
• Interventions: Device: Wevosys acoustic analysis

• Registration Number: NCT06630078
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-09-28
• Status Verified: 2024-10
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Study Start: 2024-11-30
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Case group	Wevosys acoustic analysis	children with bronchiolits, controlled asthma and asthmatic re-exacerbations and adults with primary upper aero-digestive tract affections or secondary to radiotherapy

Primary Outcome Measures

Name	Time	Method
Acoustic parameters of voice signal in children	enrollment; 24 and 48 hours post-therapy; 24 months	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases	enrollment; 24 and 48 hours post-therapy; 24 months	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Pediatric Dyspnea Scale	enrollment; 24 hours and 48 hours post-therapy; 24 months	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)
Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases	enrollment; 24 hours and 48 hours after therapy; 24 months	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)
Acoustic parameters of voice signal in adults underwent radiotherapy	enrollment; on the 30th day of radiotherapy	NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Voice Handicap Index score in adults who underwent radiotherapy	enrollment; on the 30th day of 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)
Dysphagia Handicap Index in adults who underwent radiotherapy	enrollmentt; on the 30th day of 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.

Trial Locations

Locations (2)

Jacopo Galli; 🇮🇹 Roma, Italy

Maria Raffaella Marchese; 🇮🇹 Roma, Italy