COPD ExacerbationDetectExNCT05598983
Non-contact Proactive Remote Monitoring of COPD Exacerbations
An observational study of COPD Exacerbation, run by Life Detection Technologies at 1 site in United Kingdom.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2023to 15 May 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- BMI greater than 45 kg/m2
- Nil other, provided inclusion criteria are met.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital
London
About this study
Official title: Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Ability to detect COPD exacerbations
To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.
Measured: 3 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start15 May 2023
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Life Detection Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Hurst, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598983
- Sponsor's protocol ID
- DETECT EX 001
- Acronym
- DetectEx
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05598983
- Acronym / sponsor ID
- DetectEx / DETECT EX 001
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Life Detection TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- BMI greater than 45 kg/m2
- Nil other, provided inclusion criteria are met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Track the adherence of DistaSense
Time frame: 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
Time frame: 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
Time frame: 3 - 12 months
To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Hurst principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Life Detection Technologies at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Howie (4084213151, ehowie@distasense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Track the adherence of DistaSense (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.