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Идёт набор NCT06512064

Acoustic Waveform Respiratory Evaluation

Без фазы С лечением Asthma COPD Cystic Fibrosis Ciliary Motility Disorders

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: AWARE.
Кому может быть актуально
Состояния в реестре: Asthma, COPD, Cystic Fibrosis, Ciliary Motility Disorders. Базовые параметры: 8 лет — 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) Via Sensing and Machine Learning on Smartphones

Обзор

The study will evaluate the feasibility of using smartphone speakers and microphones to evaluate the caliber of the airways, detect airway obstruction, aid in airway disease diagnosis, and identify disease exacerbations.

Подробное описание

Asthma and COPD respectively affect millions of people in the US. Chronic lower respiratory diseases represented the fourth leading cause of death in the country before the pandemic. For these and other pulmonary diseases like cystic fibrosis (CF), monitoring disease remotely but objectively could lead to marked improvements in disease control, quality of life, and overall prognosis. However, current disease monitoring and management often rely on subjective symptom report, and objective pulmonary function tests (PFTs) are often only done a handful of times a year at subspecialty referral centers. The primary hypothesis for this study is that smartphone-based sensing and machine learning (ML) approaches can advance pulmonary telemedicine by enabling comprehensive pulmonary disease evaluation with high accuracy, reliability, and adaptability. The investigators further hypothesize that AWARE can accurately help identify different lung diseases, estimate lung function, and detect changes associated with exacerbations. In Aim 1, investigators will develop and improve a smartphone sensing approach as an accurate and reliable aide in airway disease diagnosis. Investigators will recruit a sample of healthy individuals and individuals with asthma, COPD, CF, and other airway diseases, to assess whether AWARE can accurately classify subjects in their disease groups. In Aim 2, investigators will improve the ML approach to estimate lung function accurately and adaptively, including traditional PFT indices from spirometry and impulse oscillometry. And in Aim 3, investigators will develop deep learning techniques to identify changes in airway conditions associated disease exacerbations, by performing AWARE during stable disease and acute exacerbations. For these aims, investigators will recruit a cohort of pediatric and adult subjects with a wide range of demographic and anthropometric characteristics, to have adequate representation of various airway diseases, a broad range of lung function, and the ability to obtain measurements during acute disease exacerbations. The study protocol will include study questionnaires, anthropometry, body composition, and three sets of PFTs: spirometry, oscillometry, and AWARE. A subgroup of subjects will additionally perform AWARE at home for up to two weeks, allowing investigators to evaluate supervised vs unsupervised and in-clinic vs. at-home measurements. Similarly, a subgroup of subjects will perform AWARE dual testing (i.e., with both study smartphones and their own smartphone) to evaluate repeatability using diverse equipment and software platforms.

Вмешательства

  • Диагностический тест AWARE
    AWARE testing to estimate lung function and aid in disease diagnosis

Первичные конечные точки

  • Accurate and reliable disease diagnosis [Срок оценки: Up to two weeks per subject]
  • Estimation of FEV1 [Срок оценки: Up to two weeks per subject]
  • Estimation of FVC [Срок оценки: Up to two weeks per subject]
  • Estimation of FEV1/FVC [Срок оценки: Up to two weeks per subject]
  • Estimation of FEF2575 [Срок оценки: Up to two weeks per subject]
  • Estimation of R5 [Срок оценки: Up to two weeks per subject]
  • Estimation of R20 [Срок оценки: Up to two weeks per subject]
  • Estimation of R5-R20 [Срок оценки: Up to two weeks per subject]
  • Estimation of X5 [Срок оценки: Up to two weeks per subject]
  • Estimation of AX [Срок оценки: Up to two weeks per subject]
Вторичные конечные точки (11)
  • Reliable screening for disease diagnosis [Срок оценки: Up to two weeks per subject]
  • Screening of FEV1 [Срок оценки: Up to two weeks per subject]
  • Screening of FVC [Срок оценки: Up to two weeks per subject]
  • Screening of FEV1/FVC [Срок оценки: Up to two weeks per subject]
  • Screening of FEF2575 [Срок оценки: Up to two weeks per subject]
  • Screening of R5 [Срок оценки: Up to two weeks per subject]
  • Screening of R20 [Срок оценки: Up to two weeks per subject]
  • Screening of R5-R20 [Срок оценки: Up to two weeks per subject]
  • Screening of X5 [Срок оценки: Up to two weeks per subject]
  • Screening of AX [Срок оценки: Up to two weeks per subject]
  • Screening of airway changes associated disease exacerbations [Срок оценки: Up to two weeks per subject]

Критерии участия

Критерии включения

  • Age 8-70 years
  • Ability to perform spirometry and oscillometry
  • Signed informed consent (and assent for children as appropriate)
  • No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases

Критерии исключения

  • Inability or unwillingness to perform AWARE, spirometry, or oscillometry
  • Acute or chronic illness that, at the judgement of investigators, may affect lung function and alter the results of AWARE or the reference PFTs (spirometry and AOS)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 2 центра
  • Indiana University — Indianapolis
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06512064 · 20030 · R01HL170368

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗