Non-contact Proactive Remote Monitoring of COPD Exacerbations

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05598983

Acronym

DetectEx

Enrollment

Registered

2022-10-31

Start date

2023-05-15

Completion date

2026-05-15

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United Kingdom

Contacts

Primary ContactEric Howie

ehowie@distasense.com4084213151

Backup ContactPeter Rule

prule@distasense.com6502795261

Outcome results