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Integrating ePReBMs From Phoenix in Respiratory Diseases

Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From the Health Gauge Phoenix Smart Watch in Respiratory Diseases

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05827302
Enrollment
7
Registered
2023-04-25
Start date
2023-10-11
Completion date
2024-05-06
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Healthy Volunteers, Interstitial Lung Disease, Pulmonary Hypertension

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).

Interventions

DEVICEHealth Gauge AI-Based Wearable Device - Model: Phoenix

Wearable device

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Length of time wearing device6 monthsTotal length of time participant wears device

Secondary

MeasureTime frameDescription
Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations6 monthsExplore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Adverse Events6 monthsNumber of adverse events

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026