Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Acoustic parameters of voice signal in adults underwent radiotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acoustic parameters of voice signal in adults underwent radiotherapy
时间窗: 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.
Acoustic parameters of voice signal in children
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
Voice Handicap Index score in adults who underwent radiotherapy
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Galli Jacopo
Full Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS