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Recruiting NCT05598983

Non-contact Proactive Remote Monitoring of COPD Exacerbations

— Observational COPD Exacerbation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COPD Exacerbation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)

Overview

The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are: * Can an exacerbation be detected before the person recognizes they are unwell? * What are the biological signals which provide the best indication of decompensation? * How does this indication of decompensation compare to a daily CAT? Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.

Primary outcome measures

  • Track the adherence of DistaSense [Time frame: 12 months]
  • Understand the patient acceptance of DistaSense [Time frame: 12 months]
  • Ability to detect COPD exacerbations [Time frame: 3 - 12 months]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of COPD
  • 1 or more exacerbation in the last year
  • Aged over 18 years
  • Willing to use monitoring devices and complete study questionnaires
  • Adequate English
  • Signed consent form

Exclusion criteria

  • Pregnancy
  • BMI greater than 45 kg/m2
  • Nil other, provided inclusion criteria are met.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Royal Free Hospital — London

Identifiers

NCT: NCT05598983 · DETECT EX 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗