Non-contact Proactive Remote Monitoring of COPD Exacerbations

NCT05598983 | Recruiting DMC

• 1 other identifier: DETECT EX 001
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• Ability to detect COPD exacerbations

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

  3 - 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Confirmed diagnosis of COPD
• 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

You may not qualify if:

• Pregnancy
• BMI greater than 45 kg/m2

Sponsors & Collaborators

• Life Detection Technologies: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free Hospital

London, United Kingdom

RECRUITING

Study Officials

• John Hurst

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Howie

CONTACT

4084213151; ehowie@distasense.com

Peter Rule

CONTACT

6502795261; prule@distasense.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 31, 2022
• Study Start: May 15, 2023
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)