Health TrialsbyHealthPanel

Non-contact Proactive Remote Monitoring of COPD Exacerbations

ConditionCOPD Exacerbation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLife Detection Technologies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

BMI greater than 45 kg/m2

Nil other, provided inclusion criteria are met.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

75 Participants
are grouped into 2 trial groups
Group A: COPD patients
Group B: Discharged COPD patients

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

Ability to detect COPD exacerbations

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

Time frame
3 - 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Life Detection Technologies

Lead sponsor

Royal Free Hospital NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
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