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

• Conditions: COPD Exacerbation Acute
• Interventions: Device: Frontier X2

• Registration Number: NCT06419062
• Lead Sponsor: University of Strathclyde

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-17
• Study Start: 2024-07-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with COPD	Frontier X2	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.

Primary Outcome Measures

Name	Time	Method
Clinical changes before COPD exacerbations	18 months	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oakview Medical Practice in Alexandria; 🇬🇧 Glasgow, United Kingdom