Non-contact Proactive Remote Monitoring of COPD Exacerbations

Recruiting

• Conditions: COPD Exacerbation

• Registration Number: NCT05598983
• Lead Sponsor: Life Detection Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2023-05-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-05-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Understand the patient acceptance of DistaSense	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	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	3 - 12 months	To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom