Integrating ePReBMs From Phoenix in Respiratory Diseases

Not Applicable

Terminated

• Conditions: Pulmonary Hypertension; COPD; Healthy Volunteers; Interstitial Lung Disease

• Registration Number: NCT05827302
• Lead Sponsor: University of Alberta

Brief Summary

Participants with respiratory disease experience often a worsening of their condition, with increasing symptoms such as cough and shortness of breath. This worsening, often called exacerbation or flare up, impacts on the life of the participants, since they become limited in their daily activities.

Healthcare is still based today on limited times for clinical appointments to perform investigations and to meet with specialists/clinicians. Very often, these evaluations do not reflect the way the disease is limiting the patient's life.

Wearable devices offer the opportunity to collect data on physical activities and important clinical parameters (such as how the patient is active or just staying in bed during the day), on a daily basis.

The HG Phoenix AI- based Smart Watch produced by Health Gauge, an Albertan company based in Edmonton, has the potential to measure heart rate, heart rate variability, blood pressure, pulse wave velocity, respiratory rate, temperature, arterial saturation, sleep pattern (deep, light sleep, awake time), duration and time, daily physical activities (site count and distance) and calories burnt in a simple and non-invasive fashion. Ideally, these parameters could be monitored and recorded 24 hours per 7 days per week.

This study aims to demonstrate that this device can be used for a long time at home and it is comfortable to use for the participants, that it is not dangerous and, possibly, that it can help to identify exacerbations before the currently available investigations.

Detailed Description

Participants will be asked to wear the Health Gauge AI-based Wearable Device for at least 8 hours per day (ideally 24 hours), 3 days per week, for 6 months. The following data will be continuously collected from the wearable device:

heart rate, blood pressure, pulse wave velocity, respiratory rate, temperature, arterial saturation, sleep patterns, daily physical activities (step count and distance), and calories burnt.

Clinical data including demographics, radiographic, cardiac and lung functioning, diagnosis, and comorbidities will be collected from the participant's electronic medical record at baseline, 3 months, and 6 months.

Quality of life questionnaires (Saint George Respiratory Questionnaire, Medical Research Council Dyspnea Score, and EQ5-DL) will be completed by the participant through the Zamplo digital app at baseline, 3 and 6-month time points. A questionnaire on participant experience will also be administered at the 3 and 6-month time points.

Participants will be called monthly to assess patient-reported compliance with the wearable device, and adverse events (including emergency room visits and hospitalizations).

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-25
• Study Start: 2023-10-11
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Male or female volunteers, at least 18 years of age at the time of screening visit;
2. Fluent in English and able to follow the instructions to use the Health Gauge AI-based Wearable Device;
3. Willing and cognitively able to sign informed consent
4. Interstitial lung disease, chronic obstructive pulmonary disease, pulmonary hypertension, or a healthy control

Exclusion Criteria

1. Pregnancy;
2. History of active (clinically significant) skin disorders;
3. History of allergic response to plastic materials;
4. Subjects with electronic implants of any kind (e.g. pacemaker);
5. Broken, damaged or irritated skin or rashes near the sensor application sites;
6. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Exclusion Criteria for healthy control only:

1. An active medical conditions for which they are on chronic treatment with drugs;
2. Shortness of breath (any sort);
3. Chronic cough;
4. Fatigue or difficulty sleeping.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Length of time wearing device	6 months	Total length of time participant wears device

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 months	Number of adverse events
Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations	6 months	Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada