An interventional study of Wevosys acoustic analysis in Airway Disease, Cancer of Head and Neck and Radiotherapy, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 2 sites in Italy. Open to participants aged 12 Months to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 200 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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EXCLUSION CRITERIA:
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
Recording of voice signal of subjects enrolled
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: enrollmentt; on the 30th day of radiotherapy
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Sep 2025, 10 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 10 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →