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Набор скоро начнётся NCT06630078

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

Без фазы С лечением Airway Disease Cancer of Head and Neck Radiotherapy Bronchiolitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wevosys acoustic analysis.
Кому может быть актуально
Состояния в реестре: Airway Disease, Cancer of Head and Neck, Radiotherapy, Bronchiolitis. Базовые параметры: 12 мес. — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role

Обзор

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.

Вмешательства

  • Устройство Wevosys acoustic analysis
    Recording of voice signal of subjects enrolled

Первичные конечные точки

  • Acoustic parameters of voice signal in children [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in children [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in children [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in children [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases [Срок оценки: enrollment; 24 and 48 hours post-therapy; 24 months]
  • Pediatric Dyspnea Scale [Срок оценки: enrollment; 24 hours and 48 hours post-therapy; 24 months]
  • Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases [Срок оценки: enrollment; 24 hours and 48 hours after therapy; 24 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Италия · 2 центра
  • Jacopo Galli — Roma
  • Maria Raffaella Marchese — Roma

Идентификаторы

NCT: NCT06630078 · ID6812

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗