Набор скоро начнётся NCT06836375

Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.

— Наблюдательное Asthma Bronchiale

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: Spirometry test with bronchodilation, Methacholine challenge, impulse oscillometry, Measurement of the exhaled FeNO fraction.
Кому может быть актуально: Состояния в реестре: Asthma Bronchiale. Базовые параметры: 18 лет — 65 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: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial

Обзор

The objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects.

Подробное описание

The objective of this project is to detect acoustic signals generated by the respiratory system in patients with asthma using the acoustic sensor; and then, retrospectively, to use these signals to carry out signal processing research, with the aim of trying to identify signal characteristics that can be used to differentiate asthma patients from people who do not have the disease.

The hypothesis, therefore, is that it is possible to target through external smart bioelectronic devices and wireless connectivity (wearables) the initial signals of the pathophysiology of bronchial asthma and differentiate them from the signals of the normal respiratory physiology of a healthy individual.

Similarly, detection of such signals would not only be useful for asthma diagnosis but also for monitoring and early detection of exacerbations before they can be detected by the usual respiratory functional tests.

The patients will first visit the asthma unit where the diagnostic tests will be undertaken. Then the subjects will take the acoustic sensor home with them and wear it during sleep for at least two weeks.

Вмешательства

Диагностический тест Spirometry test with bronchodilation
this test measures how much air you can breathe in and out of your lungs, as well as how easily and fast you can then blow the air out of your lungs
Диагностический тест Methacholine challenge
test used to diagnose asthma where the patient breaths in methacholine
Диагностический тест impulse oscillometry
test that uses sound waves to measure how much resistance there is to the normal movement of air in and out of your lungs when you are breathing at rest
Другое Measurement of the exhaled FeNO fraction
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales

Первичные конечные точки

Acoustic respiratory signals [Срок оценки: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks]

Критерии участия

Критерии включения

Male or female, aged >= 18 and < 65.
Ability to access applications on mobile device, technical understanding and minimal technological skills
Subject has provided informed consent and is willing to comply with the study procedures.