Skip to main content
Clinical Trials/NCT05598983
NCT05598983
Recruiting
Not Applicable

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

Life Detection Technologies1 site in 1 country75 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
Life Detection Technologies
Enrollment
75
Locations
1
Primary Endpoint
Understand the patient acceptance of DistaSense
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
May 15, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Life Detection Technologies
Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Understand the patient acceptance of DistaSense

Time Frame: 12 months

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.

Track the adherence of DistaSense

Time Frame: 12 months

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.

Ability to detect COPD exacerbations

Time Frame: 3 - 12 months

To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.

Study Sites (1)

Loading locations...

Similar Trials