Pulmonary Disease, Chronic ObstructiveNCT04495062
The Use of Wearable Technology to Acquire Signals for COPD Research
An observational study of Pulmonary Disease, Chronic Obstructive, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a proven diagnosis of chronic obstructive pulmonary disease
Who may be able to join
- Patients with a diagnosis of COPD (FEV1:FVC <0.7)
Who cannot join
- Age < 18 or >80years
- Subjects who are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- For the stable patients, subjects with physical or mental impairments who would not be able to use the new technology on their own.
- Subjects with very loose/saggy skin in the neck area which would unavoidably result in the device swinging if moving the neck.
- Subjects with implantable devices
Show all 10Show fewer
- Subjects with known sleep disordered breathing
- Subjects with stridor
- Subjects requiring ventilation
- Subjects unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Respiratory Department Royal Free Hospital NHS Foundation Trust
London, NW3 2QG
About this study
Official title: Acquisition of Physiological Signals With a Wearable Technology to Assist on Research Aiming to Improve Early Identification of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. The main reason for hospitalisations associated with COPD is exacerbations (chest infections or a worsening of the underlying symptoms). Severe COPD exacerbations are the second largest cause of emergency admissions in the UK. Mild and moderate exacerbations can be managed in the community but if they are not identified promptly they may progress to breathlessness and in some patients to respiratory failure. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority for current and future COPD research. However, these still do not exist. The aim of this study will be to acquire acoustic respiratory signals from COPD patients with a small wearable device. These signals will be subsequently used to carry out engineering research with the objective of trying to find "fingerprints" in them which could be early indicators of disease exacerbations. If those "fingerprints" were found, subsequent research could focus on trying to create software methods which, together with the use of a small wearable device, would aim at automatically detecting exacerbations when they are at very early stages- prior to the symptoms being evident to the patient- so that clinical intervention could be triggered, in order to optimize the disease outcomes.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a condition characterised by progressive air-flow obstruction, decline in lung function caused by airway inflammation and damaging of air sacs. The resulting narrowing of airways makes it harder to breathe in and out. COPD is currently the fourth leading cause of death worldwide and in the UK the National Institute for Health and Clinical Excellence (NICE) estimates that the total direct cost of COPD to the NHS is over £800million - out of which £300 million correspond to hospitalisations.
Therefore, it is widely acknowledged that anything that improves management and effectiveness of treatment will not only improve patients' quality of life but also result in savings from: 1) Emergency hospital admissions; 2) Potential GP visit; 3) Loss of productivity due to work in absenteeism.
Severe COPD exacerbations (periods where there is acute worsening of respiratory symptoms such as cough, dyspnoea, wheezing, increased sputum production) cause one in eight hospital admissions. Mild and moderate exacerbations can be managed outside hospital but if not identified and treated promptly may progress in some patients to respiratory failure. A significant proportion of these exacerbations will require inpatient treatment and can reduce the quality of life of patients increasing their morbidity and mortality. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority in current and future COPD research, but currently these still do no exist.
The longer term goal of our research is to have a novel acoustic based wearable wireless technology that will be able to monitor COPD patients for extended periods of time, and automatically provide early detection of potential exacerbations even prior to symptoms which can be treated promptly to minimise their likelihood of progression to higher levels of severity.
We have developed a small wearable device which is easy to use and for the first time allows continuous non-intrusive recordings of respiratory sounds and more specifically has been designed to optimise transmission of the acoustic signals generated by airflow within the trachea.
We will aim to acquire signals from two groups of COPD patients:
- A group undergoing exacerbations
- A second group of stable, potential exacerbators, COPD patients
The group of patients undergoing exacerbations will be recruited from medical wards and patients who agree to participate in the trial will be fitted with the device during their inpatient stay. Clinical data will be collected including but not limited to: co-morbidities, medications, oxygen given; timing of exacerbations medications (antibiotics, steroids, nebulisers) and observations. Patients will also be given a diary to complete during their inpatient stay for when they are ambulating, documentation of sputum production as well as other activities. Patients will also be given the option of taking the device home for several days whilst recovering from their exacerbation.
The stable patients will be recruited from outpatient clinics and if clinically stable trained to use a device to take home for a pre-agreed period of time, up to one month. They will be expected to wear the device at night whilst sleeping and will have support throughout if needed. They will also be asked to complete a diary which documents amongst other things, sputum production, any exacerbations, symptoms, exercise and a range of other activities.
Patients in both groups will be given usability questionnaires regarding comfort, usability, ease of the device and also be invited to attend focus groups to feedback about the device.
The study will aim to develop a novel acoustic based wearable technology which will in the long term monitor COPD patients for an extended time period and automatically provide early detection of potential exacerbations. This has several benefits including:
- Disease management optimisation resulting in better quality of life and lower severity of symptoms
- Prompt and early treatment of exacerbations leading to fewer hospital admissions and can slow disease progression
- Can potentially result in more personalised treatment and management, with efficient use of drugs and reduction in treatment cost.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this work is to acquire acoustic signals from two groups of COPD patients, that can subsequently be used to carry out COPD signal processing research.
Acoustic signals from wearable technology will be collected from stable COPD patients but also patients with an exacerbation of COPD and the signals analysed for changes
Measured: Signals will be recorded for a maximum of 4 weeks
Secondary outcomes (1)
To explore the usability aspects of a small wearable device in the context of COPD patients
Usability questionnaires and patient focus and feedback groups will be used to get feedback about the device
Measured: 2 patient visits lasting a maximum 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Acurable Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495062
- Sponsor's protocol ID
- 19/NI/0194
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2020
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Physiological Signals With a Wearable Technology to Assist on Research Aiming to Improve Early Identification of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04495062
- Acronym / sponsor ID
- 19/NI/0194
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Acurable Ltd.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 31 Jul 2020 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. The main reason for hospitalisations associated with COPD is exacerbations (chest infections or a worsening of the underlying symptoms). Severe COPD exacerbations are the second largest cause of emergency admissions in the UK. Mild and moderate exacerbations can be managed in the community but if they are not identified promptly they may progress to breathlessness and in some patients to respiratory failure. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority for current and future COPD research. However, these still do not exist. The aim of this study will be to acquire acoustic respiratory signals from COPD patients with a small wearable device. These signals will be subsequently used to carry out engineering research with the objective of trying to find "fingerprints" in them which could be early indicators of disease exacerbations. If those "fingerprints" were found, subsequent research could focus on trying to create software methods which, together with the use of a small wearable device, would aim at automatically detecting exacerbations when they are at very early stages- prior to the symptoms being evident to the patient- so that clinical intervention could be triggered, in order to optimize the disease outcomes.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a condition characterised by progressive air-flow obstruction, decline in lung function caused by airway inflammation and damaging of air sacs. The resulting narrowing of airways makes it harder to breathe in and out. COPD is currently the fourth leading cause of death worldwide and in the UK the National Institute for Health and Clinical Excellence (NICE) estimates that the total direct cost of COPD to the NHS is over £800million - out of which £300 million correspond to hospitalisations.
Therefore, it is widely acknowledged that anything that improves management and effectiveness of treatment will not only improve patients' quality of life but also result in savings from: 1) Emergency hospital admissions; 2) Potential GP visit; 3) Loss of productivity due to work in absenteeism.
Severe COPD exacerbations (periods where there is acute worsening of respiratory symptoms such as cough, dyspnoea, wheezing, increased sputum production) cause one in eight hospital admissions. Mild and moderate exacerbations can be managed outside hospital but if not identified and treated promptly may progress in some patients to respiratory failure. A significant proportion of these exacerbations will require inpatient treatment and can reduce the quality of life of patients increasing their morbidity and mortality. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority in current and future COPD research, but currently these still do no exist.
The longer term goal of our research is to have a novel acoustic based wearable wireless technology that will be able to monitor COPD patients for extended periods of time, and automatically provide early detection of potential exacerbations even prior to symptoms which can be treated promptly to minimise their likelihood of progression to higher levels of severity.
We have developed a small wearable device which is easy to use and for the first time allows continuous non-intrusive recordings of respiratory sounds and more specifically has been designed to optimise transmission of the acoustic signals generated by airflow within the trachea.
We will aim to acquire signals from two groups of COPD patients:
- A group undergoing exacerbations
- A second group of stable, potential exacerbators, COPD patients
The group of patients undergoing exacerbations will be recruited from medical wards and patients who agree to participate in the trial will be fitted with the device during their inpatient stay. Clinical data will be collected including but not limited to: co-morbidities, medications, oxygen given; timing of exacerbations medications (antibiotics, steroids, nebulisers) and observations. Patients will also be given a diary to complete during their inpatient stay for when they are ambulating, documentation of sputum production as well as other activities. Patients will also be given the option of taking the device home for several days whilst recovering from their exacerbation.
The stable patients will be recruited from outpatient clinics and if clinically stable trained to use a device to take home for a pre-agreed period of time, up to one month. They will be expected to wear the device at night whilst sleeping and will have support throughout if needed. They will also be asked to complete a diary which documents amongst other things, sputum production, any exacerbations, symptoms, exercise and a range of other activities.
Patients in both groups will be given usability questionnaires regarding comfort, usability, ease of the device and also be invited to attend focus groups to feedback about the device.
The study will aim to develop a novel acoustic based wearable technology which will in the long term monitor COPD patients for an extended time period and automatically provide early detection of potential exacerbations. This has several benefits including:
- Disease management optimisation resulting in better quality of life and lower severity of symptoms
- Prompt and early treatment of exacerbations leading to fewer hospital admissions and can slow disease progression
- Can potentially result in more personalised treatment and management, with efficient use of drugs and reduction in treatment cost.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a proven diagnosis of chronic obstructive pulmonary disease
Key inclusion criteria (1 listed)
- Patients with a diagnosis of COPD (FEV1:FVC <0.7)
Key exclusion criteria (10 listed)
- Age < 18 or >80years
- Subjects who are not fluent in English, or who have special communication needs.
- Known allergy to the adhesive dressing.
- For the stable patients, subjects with physical or mental impairments who would not be able to use the new technology on their own.
- Subjects with very loose/saggy skin in the neck area which would unavoidably result in the device swinging if moving the neck.
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
The primary objective of this work is to acquire acoustic signals from two groups of COPD patients, that can subsequently be used to carry out COPD signal processing research.
Time frame: Signals will be recorded for a maximum of 4 weeks
Acoustic signals from wearable technology will be collected from stable COPD patients but also patients with an exacerbation of COPD and the signals analysed for changes
1 secondary outcome
To explore the usability aspects of a small wearable device in the context of COPD patients
Time frame: 2 patient visits lasting a maximum 1 hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Disease, Chronic Obstructive, run by Royal Free Hospital NHS Foundation Trust 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 14 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this work is to acquire acoustic signals from two groups of COPD patients, that can subsequently be used to carry out COPD signal processing research. (time frame: Signals will be recorded for a maximum of 4 weeks). 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 14 Dec 2023.