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NCT05598983 Clinical Trial

Non-contact Proactive Remote Monitoring of COPD Exacerbations

COPD Exacerbation Clinical Trial

— DetectEx  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05598983
Other study ID # DETECT EX 001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date August 15, 2024

Study information
Verified date April 2023
Source Life Detection Technologies
Contact Eric Howie
Phone 4084212039
Email ehowie@distasense.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Free Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Life Detection Technologies Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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