Airway Disease, Asthma, Bronchiolitis, Cancer of Head and Neck, Radiotherapy
Conditions
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.
Interventions
DEVICEWevosys acoustic analysis
Recording of voice signal of subjects enrolled
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acoustic parameters of voice signal in children | 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. |
| Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases | 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. |
| 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 | 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. |
| 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. |
Countries
Italy
Contacts
Primary ContactJacopo Galli
Outcome results
None listed