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

NCT06630078 | Not Yet Recruiting DMC

• 1 other identifier: ID6812
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Airway Disease; Cancer of Head and Neck; Radiotherapy; Bronchiolitis; Asthma

Outcome Measures

Primary Outcomes (16)

• 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 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

  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

• 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

• 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

• 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

• 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

Study Arms (1)

Case group

EXPERIMENTAL

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

Interventions

Wevosys acoustic analysis DEVICE

Recording of voice signal of subjects enrolled

Case group

Eligibility Criteria

• Age: 12 Months - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children with comorbidities including genetic disorders;
• Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);
• Children with primary immunologic diseases;
• Children with prematurity;
• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Jacopo Galli

Roma, 00168, Italy

Location

Maria Raffaella Marchese

Roma, 00198, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Bronchiolitis; Asthma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jacopo Galli

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacopo Galli

CONTACT

+393338356370; jacopo.galli@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: October 8, 2024
• Study Start: November 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)