Clinical trial NCT05827302: Integrating ePReBMs From Phoenix in Respiratory Diseases
Official title: Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From the Health Gauge Phoenix Smart Watch in Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Hypertension
COPD
Interstitial Lung Disease
Healthy Volunteers
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will compare healthy controls to those with respiratory disease. Both groups will be wearing the watch and completing the same questionnaires
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Length of time wearing device
timeFrame: 6 months
Secondary outcomes:
measure: Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References: