COPD Exacerbation Acute
Conditions
Keywords
medical device, remote monitoring technologies, respiratory signal
Brief summary
The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.
Detailed description
The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.
Interventions
DEVICEPneumowave DC
Pneumowave biosensor(s) will be used to collect data from chest +/- movement.
Sponsors
Pneumowave Ltd
University of Strathclyde
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any person aged 18 years or over. * Current diagnosis of COPD. * Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'. * Be able to give written consent. * Able to understand written and spoken English.
Exclusion criteria
* Inability to give written informed consent. * Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis). * Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders). * Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ). * Based on their medical record if there is any social violence/substance misuse. * Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months. * Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. * Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months. * Pregnancy * Patients already involved in an ongoing research study. * Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life. * Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons. * Known allergy to surgical adhesive tape. * On long-term oxygen therapy. * Acute exacerbation of COPD within 6 weeks prior to inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical changes before COPD exacerbations | 18 months | Participants' breath rates will be measured through chest movement in their daily lives, and clinical changes in their breath rates will be examined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device usage | 18 months | • To assess the usability and comfort of the wearable technology, assessed by qualitative interviews and field notes during fortnightly follow-up appointments from the perspective of the volunteer |
Countries
United Kingdom
Outcome results
None listed