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Enrolling by Invitation

NCT Number: NCT06419062

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

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

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakview Medical Practice in Alexandria

Glasgow, G83 0UE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frontier X2

Device

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

Primary outcomes

  1. Clinical changes before COPD exacerbations

    Time frame: 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 outcomes

  1. Device usage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Strathclyde

Other

Collaborators

  • Fourth Frontier Technologies Ltd

Registry information

Official study title

The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study

Acronym: BREATH-TRACHER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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