Learn about Research & Clinical Trials

Integrating ePReBMs From Phoenix in Respiratory Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05827302
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alberta
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, COPD, Interstitial Lung Disease, Healthy Volunteers

Additional Details

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).

Arms & Interventions

Arms

Experimental: Device: Health Gauge AI-Based Wearable Device - Model: Phoenix

Interventions

Device: - Health Gauge AI-Based Wearable Device - Model: Phoenix

Wearable device

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.