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Набор по приглашению NCT06419036

The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1

— Наблюдательное COPD Exacerbation Acute

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: Pneumowave DC.
Кому может быть актуально
Состояния в реестре: COPD Exacerbation Acute. Базовые параметры: от 18 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
Великобритания
Следующий шаг
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Официальное название

The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study

Обзор

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

Подробное описание

The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.

Вмешательства

  • Устройство Pneumowave DC
    Pneumowave biosensor(s) will be used to collect data from chest +/- movement.

Первичные конечные точки

  • Clinical changes before COPD exacerbations [Срок оценки: 18 months]
Вторичные конечные точки (1)
  • Device usage [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • Any person aged 18 years or over.
  • Current diagnosis of COPD.
  • Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
  • Be able to give written consent.
  • Able to understand written and spoken English.

Критерии исключения

  • Inability to give written informed consent.
  • Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
  • Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
  • Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
  • Based on their medical record if there is any social violence/substance misuse.
  • Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
  • Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
  • Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
  • Pregnancy
  • Patients already involved in an ongoing research study.
  • Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
  • Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
  • Known allergy to surgical adhesive tape.
  • On long-term oxygen therapy.
  • Acute exacerbation of COPD within 6 weeks prior to inclusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Oakview Medical Practice in Alexandria — Glasgow

Публикации

  • Hawthorne G, Richardson M, Greening NJ, Esliger D, Briggs-Price S, Chaplin EJ, Clinch L, Steiner MC, Singh SJ, Orme MW. A proof of concept for continuous, non-invasive, free-living vital signs monitoring to predict readmission following an acute exacerbation of COPD: a prospective cohort study. Respir Res. 2022 Apr 26;23(1):102. doi: 10.1186/s12931-022-02018-5. PMID 35473718
  • Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11. PMID 19554195
  • Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC. PMID 26151174

Идентификаторы

NCT: NCT06419036 · UEC23/51

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗