CClinicalTrials.gg
Sign In
Enrolling by invitationNCT06419062BREATH-TRACHERUpdated Apr 10, 2025

The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2

An observational study in COPD Exacerbation Acute, sponsored by University of Strathclyde. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by University of Strathclyde · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This study will assess the sensitivity of a wearable device to measure the physiological signals in COPD patients, who have previously experienced hospitalization due to exacerbation of their COPD.

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.

02

Conditions studied

  • COPD Exacerbation Acute

Keywords

  • medical device
  • remote monitoring technologies
  • respiratory signal
  • heart rate
  • ECG
03

In context

Lead sponsor

University of Strathclyde is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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 strap.
  • On long-term oxygen therapy.
  • Acute exacerbation of COPD within 6 weeks prior to inclusion.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • People 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: Frontier X2

Interventions

  • DeviceFrontier X2

    Frontier X2 device will be used to measuring for physiological changes (breathing rate, heart rate, ECG, and heart rate variabilities) in people with COPD.

06

What researchers measure

Primary outcomes

  1. Clinical changes before COPD exacerbations

    Participants' breath rates, heart rate and ECG levels will be measured in their daily lives, and clinical changes will be examined when the clinical health of a COPD sufferer is starting to deteriorate.

    Time frame: 18 months

Secondary outcomes

  1. Device usage

    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

    Time frame: 18 months

07

Study locations

1 site
  • Oakview Medical Practice in Alexandria
    Glasgow, G83 0UE, United Kingdom
08

References and documents

Publications

  • 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. PubMed 35473718 ↗
  • 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. PubMed 19554195 ↗
  • 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. PubMed 26151174 ↗

Individual participant data

Plan to share: No — All data collected during the study will be immediately anonymized and will not be shared with third parties.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419062
Lead sponsor
University of Strathclyde
Collaborators
Fourth Frontier Technologies Ltd
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Jul 3, 2024
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Apr 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Strathclyde

Start the discussion