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NCT Number: NCT06630078

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

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.

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Key information

Conditions

Airway Disease Asthma Bronchial Diseases Bronchiolitis Bronchitis Cancer of Head and Neck Head and Neck Neoplasms Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Neoplasms Neoplasms by Site Radiotherapy Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

12 month–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacopo Galli, Roma, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wevosys acoustic analysis

Device

Recording of voice signal of subjects enrolled

Primary outcomes

  1. Acoustic parameters of voice signal in children

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    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.

  2. Acoustic parameters of voice signal in children

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.

  3. Acoustic parameters of voice signal in children

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    Shimmer (%) relates to the amplitude variation of the sound wave.

  4. Acoustic parameters of voice signal in children

    Time frame: 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.

  5. Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    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.

  6. Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle; Shimmer (%) relates to the amplitude variation of the sound wave.

  7. Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases

    Time frame: enrollment; 24 and 48 hours post-therapy; 24 months

    Shimmer (%) relates to the amplitude variation of the sound wave.

  8. Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases

    Time frame: 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.

  9. Pediatric Dyspnea Scale

    Time frame: 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)

  10. Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases

    Time frame: 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)

  11. Acoustic parameters of voice signal in adults underwent radiotherapy

    Time frame: enrollment; on the 30th day of 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.

  12. Acoustic parameters of voice signal in adults underwent radiotherapy

    Time frame: enrollment; on the 30th day of radiotherapy

    Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.

  13. Acoustic parameters of voice signal in adults underwent radiotherapy

    Time frame: enrollment; on the 30th day of radiotherapy

    Shimmer (%) relates to the amplitude variation of the sound wave.

  14. Acoustic parameters of voice signal in adults underwent radiotherapy

    Time frame: 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.

  15. Voice Handicap Index score in adults who underwent radiotherapy

    Time frame: 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)

  16. Dysphagia Handicap Index in adults who underwent radiotherapy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacopo Galli

CONTACT

[email protected]

+393338356370

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: AIRWAY-VDAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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