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

COPD Exacerbation Acute Clinical Trial

— BREATH-TRACHER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419062
• Other study ID #: UEC23/71
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: May 2024
• Source: University of Strathclyde
• Contact: Alex Mullen, PhD
• Phone: 441415484409
• Email: a.mullen[@]strath.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation Acute

Intervention

Device:
• Frontier 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.

Locations

Country	Name	City	State
United Kingdom	Oakview Medical Practice in Alexandria	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Strathclyde	Fourth Frontier Technologies Ltd

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	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	18 months