Non-contact Proactive Remote Monitoring of COPD Exacerbations

NCT ID: NCT05598983

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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COPD Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Life Detection Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Hurst

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Eric Howie

Role: CONTACT

4084213151

Peter Rule

Role: CONTACT

6502795261

Other Identifiers

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DETECT EX 001

Identifier Type: -

Identifier Source: org_study_id

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