COPD Exacerbation Clinical Trial
— DetectExOfficial title:
Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
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.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | August 15, 2024 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Confirmed diagnosis of COPD 2. 1 or more exacerbation in the last year 3. Aged over 18 years 4. Willing to use monitoring devices and complete study questionnaires 5. Adequate English 6. Signed consent form Exclusion Criteria: 1. Pregnancy 2. BMI greater than 45 kg/m2 3. Nil other, provided inclusion criteria are met. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Free Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Life Detection Technologies | Royal Free Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Track the adherence of DistaSense | To evaluate the adherence of patients using DistaSense, a non-contact vital sign monitor that measures heart rate and respiration rate, we will be tracking the patient dropout rate over the course of the 12 month study period. | 12 months | |
Primary | Understand the patient acceptance of DistaSense | To evaluate the patient acceptance of using DistaSense, a non-contact vital sign monitor that measures heart rate and respiration rate, we will be requesting patients complete a Technology Assessment Model Fast Form (TAM-FF) every 3 months during the 12 month trial period. | 12 months | |
Primary | Ability to detect COPD exacerbations | To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD. | 3 - 12 months |
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