Non-contact Proactive Remote Monitoring of COPD Exacerbations (DetectEx)

March 19, 2025 updated by: Life Detection Technologies

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Free Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death affecting an estimated 238 million worldwide. It is a heterogeneous disease which is characterized by air flow obstruction and decline in lung function with symptoms of shortness of breathing, sputum, and cough.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
COPD patients
Group will consist of individuals who have been diagnosed with COPD, living in their home and not recently discharged from the hospital for an exacerbation.
Discharged COPD patients
Group will consist of individuals who have been diagnosed with COPD, living in their home, and are being discharged from the hospital for an exacerbation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
3 - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life Detection Technologies

Collaborators

Royal Free Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: John Hurst, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DETECT EX 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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