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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wevosys acoustic analysis | Device | Recording of voice signal of subjects enrolled |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacopo Galli | Contact | +393338356370 | jacopo.galli@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Jacopo Galli | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacopo Galli | Roma | 00168 | Italy |
|
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| 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 |
| Maria Raffaella Marchese | Roma | 00198 | Italy |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D001988 | Bronchiolitis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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