DetectEx: Non-contact Proactive Remote Monitoring of COPD Exacerbations

Sponsor

Life Detection Technologies (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05598983

Collaborator

Royal Free Hospital NHS Foundation Trust (Other)

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Jun 15, 2024

Anticipated Study Completion Date :

Jun 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.
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.
Ability to detect COPD exacerbations [3 - 12 months]
To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Free Hospital	London		United Kingdom

Sponsors and Collaborators

Life Detection Technologies
Royal Free Hospital NHS Foundation Trust

Investigators

Principal Investigator: John Hurst, University College, London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Life Detection Technologies

ClinicalTrials.gov Identifier:

NCT05598983

Other Study ID Numbers:

DETECT EX 001

First Posted:

Oct 31, 2022

Last Update Posted:

Nov 3, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 3, 2022