The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1

NCT06419036 | Enrolling By Invitation

• 1 other identifier: UEC23/51
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

Conditions

COPD Exacerbation Acute

Keywords

medical device; remote monitoring technologies; respiratory signal

Outcome Measures

Primary Outcomes (1)

• Clinical changes before COPD exacerbations

  Participants' breath rates will be measured through chest movement in their daily lives, and clinical changes in their breath rates will be examined.

  18 months

Secondary Outcomes (1)

• Device usage

  18 months

Study Arms (1)

Patients with COPD

The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment.

Device: Pneumowave DC

Interventions

Pneumowave DC DEVICE

Pneumowave biosensor(s) will be used to collect data from chest +/- movement.

Patients with COPD

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

The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. The target number of participants in this study is 30.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Strathclyde: lead
• Pneumowave Ltd: collaborator

Study Sites (1)

Oakview Medical Practice in Alexandria

Glasgow, G83 0UE, United Kingdom

Location

Related Publications (3)

• Hawthorne G, Richardson M, Greening NJ, Esliger D, Briggs-Price S, Chaplin EJ, Clinch L, Steiner MC, Singh SJ, Orme MW. A proof of concept for continuous, non-invasive, free-living vital signs monitoring to predict readmission following an acute exacerbation of COPD: a prospective cohort study. Respir Res. 2022 Apr 26;23(1):102. doi: 10.1186/s12931-022-02018-5.

  PMID: 35473718 BACKGROUND

• Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11.

  PMID: 19554195 BACKGROUND

• Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC.

  PMID: 26151174 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: May 17, 2024
• Study Start: June 24, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)