## Protocol Section
### Identification Module
**NCT ID:** NCT06419062

**Acronym:** BREATH-TRACHER

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

**Official Title:** The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study

#### Organization Study ID Info
**ID:** UEC23/71
#### Organization
**Class:** OTHER
**Full Name:** University of Strathclyde
### Status Module
#### Completion Date
**Date:** 2025-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-28
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Fourth Frontier Technologies Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Strathclyde

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- COPD Exacerbation Acute

**Keywords:**

- medical device

- remote monitoring technologies

- respiratory signal

- heart rate

- ECG

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Frontier X2

**Label:** People with COPD

### Interventions

#### Intervention 1

**Arm Group Labels:**

- People with COPD

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

**Name:** Frontier X2

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Clinical changes before COPD exacerbations

**Time Frame:** 18 months

#### Secondary Outcomes

**Description:** 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

**Measure:** Device usage

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** a.mullen@strath.ac.uk

**Name:** Alex Mullen, PhD

**Phone:** 441415484409

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Glasgow

**Contacts:**

***Contact 1:***

- **Email:** a.mullen@strath.a.cuk

- **Name:** Alexander Mullen

- **Phone:** +44 (0) 1415484409

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Oakview Medical Practice in Alexandria

**Zip:** G83 0UE

### IPD Sharing Statement Module

**Description:** All data collected during the study will be immediately anonymized and will not be shared with third parties.

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 35473718

**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.

**PMID:** 19554195

**Citation:** 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

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
