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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Children with comorbidities including genetic disorders;

Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);

Children with primary immunologic diseases;

Children with prematurity;

Trial design

Design model

Single group

Treatments tested in this trial

  • Wevosys acoustic analysis

    Device

    Recording of voice signal of subjects enrolled

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Case groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
enrollment; 24 and 48 hours post-therapy; 24 months
2

Acoustic parameters of voice signal in children

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

Time frame
enrollment; 24 and 48 hours post-therapy; 24 months
3

Acoustic parameters of voice signal in children

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

Time frame
enrollment; 24 and 48 hours post-therapy; 24 months
4

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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