Pulmonary HypertensionNCT05827302
Integrating ePReBMs From Phoenix in Respiratory Diseases
A study testing Health Gauge AI-Based Wearable Device - Model: Phoenix in people with Pulmonary Hypertension and COPD, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, COPD, Interstitial Lung Disease
- What is being tested?
- Health Gauge AI-Based Wearable Device - Model: Phoenix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- An active medical conditions for which they are on chronic treatment with drugs;
- Shortness of breath (any sort);
- Chronic cough;
- Fatigue or difficulty sleeping.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From the Health Gauge Phoenix Smart Watch in Respiratory Diseases
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.
Read more
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.
Read the 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).
- Being tested
- Health Gauge AI-Based Wearable Device - Model: Phoenix
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Gauge AI-Based Wearable Device - Model: PhoenixDevice
Wearable device
| Study group | Role | What they receive |
|---|---|---|
| Device: Health Gauge AI-Based Wearable Device - Model: Phoenix | Experimental | Not described Receives: Device: Health Gauge AI-Based Wearable Device - Model: Phoenix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time wearing device
Total length of time participant wears device
Measured: 6 months
Secondary outcomes (2)
Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Measured: 6 months
Adverse Events
Number of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start11 Oct 2023
- Primary completion6 May 2024
- Study completion6 May 2024
Why it stopped: Resource Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827302
- Sponsor's protocol ID
- Pro00125759
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From the Health Gauge Phoenix Smart Watch in Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05827302
- Acronym / sponsor ID
- Pro00125759
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resource Issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Device: Health Gauge AI-Based Wearable Device - Model: Phoenix | Experimental | Device: Health Gauge AI-Based Wearable Device - Model: Phoenix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Gauge AI-Based Wearable Device - Model: PhoenixWearable device | Device | Device: Health Gauge AI-Based Wearable Device - Model: Phoenix |
Primary outcome
Length of time wearing device
Time frame: 6 months
Total length of time participant wears device
2 secondary outcomes
Prediction of respiratory exacerbations- Number of emergency room visits or hospitalizations
Time frame: 6 months
Adverse Events
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Resource Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Gauge AI-Based Wearable Device - Model: Phoenix in people with Pulmonary Hypertension and COPD, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resource Issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time wearing device (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.