Preterm BirthNCT04956354
The Use of Wireless Sensors in Neonatal Intensive Care
An observational study of Preterm Birth and Apnea of Newborn, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring… Read more about this study
- Who is it for?
- Ages 6 hours to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Apnea of Newborn
- What is being tested?
- ANNE™ Monitoring System (2 sensors) - version B and ANNE™ Monitoring System (2 sensors) - version C
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2022to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 hours to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants admitted to the NICU at the Montreal Children's Hospital with different levels of maturity/clinical conditions.
Who may be able to join
- Healthy term infants in room air at enrollment
- Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment
- Healthy preterm infants in room air at enrollment
- Preterm infants on continuous positive airway pressure at enrollment
- Preterm infants on conventional mechanical ventilation at enrollment
- Preterm infants on high frequency ventilation at enrollment
- Preterm infants on nasal intermittent positive end expiratory pressure at enrollment
- Preterm infants on continuous positive airway pressure at enrollment
Who cannot join
- Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia)
- Congenital heart disorders
- Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously.
Study objectives include:
- Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU.
- Assess safety of using a special wireless sensor system in neonates.
- Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Read the detailed description
Infants admitted in the NICU are all subject to continuous monitoring of vital signs such as heart rate, respirations and oxygen saturation (SpO2) by placing sensors, leads, or bands directly on infant's skin and connecting them to monitors via wires. However, despite the rapid technological advances in wireless monitoring and wearable devices across various industries, the health care sector has traditionally lagged. Therefore, the investigators aim to explore the safety and effectiveness of wireless monitoring (ANNE™ Monitoring System) and compare it with the traditional wired monitoring system on infants with variable degrees of maturity in the NICU.
More specifically, the investigators aim to examine (1) if it is feasible and to implement a wireless monitoring system in both term and preterm infants in the NICU; (2) if it is safe to use this particular wireless monitoring system among neonates; and (3) the accuracy of the wireless monitoring technology compared to the stand-of-care monitoring in the NICU.
- Conditions
- Preterm Birth, Apnea of Newborn
- Being tested
- ANNE™ Monitoring System (2 sensors) - version B, ANNE™ Monitoring System (2 sensors) - version C
- Keywords
- Continuous monitoring, NICU, Wireless sensors
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE™ Monitoring System (2 sensors) - version BDevice
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are:
Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements.
Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
ANNE™ Monitoring System (2 sensors) - version CDevice
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are:
Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature.
Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
ANNE™ Monitoring System (2 sensors) - version CDevice
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are:
Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature.
Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a | Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for 8h during daytime, for 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal.
Hourly axillary temperature measured by the bedside nurse (as part of routine care) will be manually recorded for each patient by the research team. A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. Receives: Device: ANNE™ Monitoring System (2 sensors) - version B | |
| Phase 1b | Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired between 2h to 8h during daytime, for 2 to 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal.
A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. Receives: Device: ANNE™ Monitoring System (2 sensors) - version C | |
| Phase 2 | Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for a longer monitoring period - i.e., 96 consecutive hours. In consideration with device battery life, the devices will be replaced daily. In addition, photographs of the skin at the site of placement of the sensors will be taken at baseline, device replacement, and at 96h. The research team will also measure respirations using uncalibrated RIP belts at the level of the chest and abdomen (2 to 3 continuous hours each day). Two respiratory bands will be placed circumferentially around the infant's chest and around the abdomen to measure chest and abdominal wall movements, respectively.
A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. Receives: Device: ANNE™ Monitoring System (2 sensors) - version C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of wireless wearable heart rate data
Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.
Measured: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable respiratory rate data
Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.
Measured: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable skin temperature data
Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.
Measured: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable oxygen saturation (SpO2) data
Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.
Measured: 4 consecutive days of wireless monitoring
Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts
Proportion of monitoring time exhibiting unreliable wireless device signals due to significant movement artifacts. The exact definition of unreliable for each of the signals will be outlined before study initiation.
Measured: 4 consecutive days of wireless monitoring
Proportion of time with loss of network connections or other technical problems
Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring.
Measured: 4 consecutive days of wireless monitoring
Skin integrity at the sites of sensor placement
Skin integrity at the site of wireless lead placements from de-identified digital photographs, evaluated by a board-certified dermatologist who will evaluate for signs of irritation, redness and/or erosions.
Measured: 4 consecutive days of wireless monitoring
Evaluation of potential subjective pain experienced by infant at time of sensor removal
Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal.
Measured: 4 consecutive days of wireless monitoring
Clinicians', nursing, and parental perceptions
Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.
Measured: 4 consecutive days of wireless monitoring
Secondary outcomes (6)
Automated reports of physiological health - electrocardiogram
Automated reports for electrocardiogram acquired from the wireless monitoring device
Measured: 4 consecutive days of wireless monitoring
Automated reports of physiological health - respiratory waveforms
Automated reports for respiratory waveforms acquired from the wireless monitoring device
Measured: 4 consecutive days of wireless monitoring
Automated reports of physiological health - oxygen saturation
Automated reports for oxygen saturation acquired from the wireless monitoring device
Measured: 4 consecutive days of wireless monitoring
Automated reports of physiological health - temperature
Automated reports for temperature acquired from the wireless monitoring device
Measured: 4 consecutive days of wireless monitoring
Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device
For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with RIP (the gold standard) with the simultaneously recorded wireless monitoring device data.
Measured: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Enhanced respiratory monitoring using accelerometry
For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with thoracic impedance (the current standard) with the simultaneously recorded wireless monitoring device data.
Measured: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Aug 2022
- Primary completion23 Sep 2024
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Northwestern University
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme M Sant'Anna, MD PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreWissam Shalish, MD PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreRobert E Kearney, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956354
- Sponsor's protocol ID
- Wireless NICU
- Status last verified
- May 2026
- First submitted
- 11 Jun 2021
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
- ClinicalTrials.gov ID
- NCT04956354
- Acronym / sponsor ID
- Wireless NICU
- Conditions
- Preterm Birth, Apnea of Newborn
- Keywords
- Continuous monitoring, NICU, Wireless sensors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- McGill University, Northwestern University
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Jul 2021 (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.
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously.
Study objectives include:
- Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU.
- Assess safety of using a special wireless sensor system in neonates.
- Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Detailed description
Infants admitted in the NICU are all subject to continuous monitoring of vital signs such as heart rate, respirations and oxygen saturation (SpO2) by placing sensors, leads, or bands directly on infant's skin and connecting them to monitors via wires. However, despite the rapid technological advances in wireless monitoring and wearable devices across various industries, the health care sector has traditionally lagged. Therefore, the investigators aim to explore the safety and effectiveness of wireless monitoring (ANNE™ Monitoring System) and compare it with the traditional wired monitoring system on infants with variable degrees of maturity in the NICU.
More specifically, the investigators aim to examine (1) if it is feasible and to implement a wireless monitoring system in both term and preterm infants in the NICU; (2) if it is safe to use this particular wireless monitoring system among neonates; and (3) the accuracy of the wireless monitoring technology compared to the stand-of-care monitoring in the NICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a | – | Device: ANNE™ Monitoring System (2 sensors) - version BOnce the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for 8h during daytime, for 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal. Hourly axillary temperature measured by the bedside nurse (as part of routine care) will be manually recorded for each patient by the research team. A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. |
| Phase 1b | – | Device: ANNE™ Monitoring System (2 sensors) - version COnce the setup of the study sensors is complete, clinical and physiological data will be continuously acquired between 2h to 8h during daytime, for 2 to 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal. A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. |
| Phase 2 | – | Device: ANNE™ Monitoring System (2 sensors) - version COnce the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for a longer monitoring period - i.e., 96 consecutive hours. In consideration with device battery life, the devices will be replaced daily. In addition, photographs of the skin at the site of placement of the sensors will be taken at baseline, device replacement, and at 96h. The research team will also measure respirations using uncalibrated RIP belts at the level of the chest and abdomen (2 to 3 continuous hours each day). Two respiratory bands will be placed circumferentially around the infant's chest and around the abdomen to measure chest and abdominal wall movements, respectively. A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity. |
Who may qualify
- Ages
- 6 hours to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants admitted to the NICU at the Montreal Children's Hospital with different levels of maturity/clinical conditions.
Key inclusion criteria (8 listed)
- Healthy term infants in room air at enrollment
- Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment
- Healthy preterm infants in room air at enrollment
- Preterm infants on continuous positive airway pressure at enrollment
- Preterm infants on conventional mechanical ventilation at enrollment
Key exclusion criteria (3 listed)
- Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia)
- Congenital heart disorders
- Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
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 |
|---|---|---|
| ANNE™ Monitoring System (2 sensors) - version BANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals. | Device | Phase 1a |
| ANNE™ Monitoring System (2 sensors) - version CANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals. | Device | Phase 1b |
| ANNE™ Monitoring System (2 sensors) - version CANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals. | Device | Phase 2 |
Primary outcome
Accuracy of wireless wearable heart rate data
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable respiratory rate data
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable skin temperature data
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable oxygen saturation (SpO2) data
Time frame: 4 consecutive days of wireless monitoring
Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.
Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts
Time frame: 4 consecutive days of wireless monitoring
Proportion of monitoring time exhibiting unreliable wireless device signals due to significant movement artifacts. The exact definition of unreliable for each of the signals will be outlined before study initiation.
Proportion of time with loss of network connections or other technical problems
Time frame: 4 consecutive days of wireless monitoring
Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring.
Skin integrity at the sites of sensor placement
Time frame: 4 consecutive days of wireless monitoring
Skin integrity at the site of wireless lead placements from de-identified digital photographs, evaluated by a board-certified dermatologist who will evaluate for signs of irritation, redness and/or erosions.
Evaluation of potential subjective pain experienced by infant at time of sensor removal
Time frame: 4 consecutive days of wireless monitoring
Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal.
Clinicians', nursing, and parental perceptions
Time frame: 4 consecutive days of wireless monitoring
Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.
6 secondary outcomes
Automated reports of physiological health - electrocardiogram
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - respiratory waveforms
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - oxygen saturation
Time frame: 4 consecutive days of wireless monitoring
Automated reports of physiological health - temperature
Time frame: 4 consecutive days of wireless monitoring
Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device
Time frame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Enhanced respiratory monitoring using accelerometry
Time frame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Guilherme M Sant'Anna, MD PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Wissam Shalish, MD PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Robert E Kearney, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Apnea of Newborn, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of wireless wearable heart rate data (time frame: 4 consecutive days of wireless monitoring). The study lists 9 primary outcomes in all. 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 8 May 2026.