Integrating ePReBMs From Phoenix in Respiratory Diseases

NCT05827302 | Terminated

• 1 other identifier: Pro00125759
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; COPD; Interstitial Lung Disease; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Length of time wearing device

  Total length of time participant wears device

  6 months

Secondary Outcomes (2)

• Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations

  6 months

• Adverse Events

  6 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Wearable device

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy;
• History of active (clinically significant) skin disorders;
• History of allergic response to plastic materials;
• Subjects with electronic implants of any kind (e.g. pacemaker);
• Broken, damaged or irritated skin or rashes near the sensor application sites;
• Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
• An active medical conditions for which they are on chronic treatment with drugs;
• Shortness of breath (any sort);
• Chronic cough;
• Fatigue or difficulty sleeping.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will compare healthy controls to those with respiratory disease. Both groups will be wearing the watch and completing the same questionnaires

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 25, 2023
• Study Start: October 11, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

CA (1)