HealthyNCT03661606
Biovitals Analytics Engine - Altitude Study
A study testing Simulated Altitude Chamber in people with Healthy, run by Biofourmis Singapore Pte Ltd. at 1 site in Singapore.
Trial summary
Unexpected adverse health events resulting in a hospital admission can be potentially avoided by leveraging novel physiological sensors combined with advanced computational techniques to predict changes in physiology prior to the onset of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Simulated Altitude Chamber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Jul 2018to 4 Oct 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 Male or female, voluntary adults aged between ≥ 18 to ≤ 65 years
- Ability to read and understand basic English Language
- Women who are of childbearing potential, must if sexually active, agree to use appropriate contraceptive measures for the duration of the study
- Able to perform all activities in the study procedure
Who cannot join
- High altitude residents (>500m)
- Anemic
- Athlete
- Lung, airways and/or sinus pathology
- Previous myocardial infarction or coronary revascularization (PCI or CABG)
- Any prior history of heart failure
Show all 11Show fewer
- Any prior history of moderate or severe valvular heart disease
- Any history of pulmonary disease (asthma, emphysema/ COPD, pulmonary hypertension)
- Any other medical condition or functional problems (e.g. previous intolerance or current contraindication to altitude, unable to exercise, skin problems, schizophrenia and bipolar disorder) that in the judgment of the investigator will impair the subjects ability to complete the processes needed in the clinical study
- Unable or unwillingness to sign the informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Effect of High Altitude (Hypoxia) on an Individual's Physiology - an Analytical Study to Validate the Performance of the Biovitals™ Analytics Engine (BA Engine - Altitude Study)
Unexpected adverse health events resulting in a hospital admission can be potentially avoided by leveraging novel physiological sensors combined with advanced computational techniques to predict changes in physiology prior to the onset of symptoms. In other words, significant improvement in the prevention of avoidable hospitalization can be achieved via early detection and actionable insights of clinical deterioration at the individual patient level as they go about their normal day to day activities. Physiological changes can be a warning sign that a person's health is deteriorating and as such is an important component of an early detection tool.
The Biovitals Analytics Engine (BA Engine) is intended to be used with data from already validated sensors measuring physiological parameters, including heart rate (HR), respiratory rate (RR) and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a continuous output- Biovitals™ Index (BI) which indicates whether the relationships among the patients monitored vital signs change from those measured at baseline (derived from measurements previously obtained during daily routine activities). The BI is based on an integrated computation evaluating changes in the parameters and their relationship to each other.
As part of the clinical validation of the BA Engine, it is important to first undertake an analytical validation to demonstrate that the BA correctly processes the physiological data for which it is designed, and generates an accurate detection of physiological change. In order to generate a measurable physiological change, subjects will move from sea level to an altitude environment which is known to cause increases in HR and RR.
Read the detailed description
Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days.
Measurements will be taken at sea level (baseline), during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individual's physiological baseline. On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude (intervention) chamber with an altitude change of 3000 meters. At the chamber site, the subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours. In the chamber, subjects will be asked to remain seated. At the completion of the chamber run, subjects will hand back the device and smartphone and complete a user experience survey. A follow-up phone call to check on subjects will then be done on day 5 before closing the study.
- Conditions
- Healthy
- Being tested
- Simulated Altitude Chamber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Altitude ChamberOther
Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days.
Measurements will be taken at sea level (baseline), during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individual's physiological baseline. On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude (intervention) chamber with altitude change of 3000 meters. At the chamber site, subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours. In the chamber, subjects will be asked to remain seated. At the completion of the chamber run, subjects will hand back the device and smartphone and complete a user experience survey. A follow up phone call to check on subjects will then be done on day 5 before closing the study.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring arm | Experimental | Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days. Receives: Other: Simulated Altitude Chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical validation testing of the BA Engine's output
This study aims to demonstrate that the BA Engine correctly processes monitored physiological data to generate accurate, reliable and precise detection of changes in an individual's physiology at high altitude (3000m) when compared to their baseline physiology at sea-level, as per its design specifications and to meet its intended use.
Measured: Changes in subjects physiology at an altitude of 3000m compared to baseline physiology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Jul 2018
- Primary completion30 Sep 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofourmis Singapore Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661606
- Sponsor's protocol ID
- PIEC/2018/013
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of High Altitude (Hypoxia) on an Individual's Physiology - an Analytical Study to Validate the Performance of the Biovitals™ Analytics Engine (BA Engine - Altitude Study)
- ClinicalTrials.gov ID
- NCT03661606
- Acronym / sponsor ID
- PIEC/2018/013
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biofourmis Singapore Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 7 Sep 2018 (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.
Unexpected adverse health events resulting in a hospital admission can be potentially avoided by leveraging novel physiological sensors combined with advanced computational techniques to predict changes in physiology prior to the onset of symptoms. In other words, significant improvement in the prevention of avoidable hospitalization can be achieved via early detection and actionable insights of clinical deterioration at the individual patient level as they go about their normal day to day activities. Physiological changes can be a warning sign that a person's health is deteriorating and as such is an important component of an early detection tool.
The Biovitals Analytics Engine (BA Engine) is intended to be used with data from already validated sensors measuring physiological parameters, including heart rate (HR), respiratory rate (RR) and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a continuous output- Biovitals™ Index (BI) which indicates whether the relationships among the patients monitored vital signs change from those measured at baseline (derived from measurements previously obtained during daily routine activities). The BI is based on an integrated computation evaluating changes in the parameters and their relationship to each other.
As part of the clinical validation of the BA Engine, it is important to first undertake an analytical validation to demonstrate that the BA correctly processes the physiological data for which it is designed, and generates an accurate detection of physiological change. In order to generate a measurable physiological change, subjects will move from sea level to an altitude environment which is known to cause increases in HR and RR.
Detailed description
Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days.
Measurements will be taken at sea level (baseline), during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individual's physiological baseline. On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude (intervention) chamber with an altitude change of 3000 meters. At the chamber site, the subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours. In the chamber, subjects will be asked to remain seated. At the completion of the chamber run, subjects will hand back the device and smartphone and complete a user experience survey. A follow-up phone call to check on subjects will then be done on day 5 before closing the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring arm | Experimental | Other: Simulated Altitude ChamberSubjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 Male or female, voluntary adults aged between ≥ 18 to ≤ 65 years
- Ability to read and understand basic English Language
- Women who are of childbearing potential, must if sexually active, agree to use appropriate contraceptive measures for the duration of the study
- Able to perform all activities in the study procedure
Key exclusion criteria (11 listed)
- High altitude residents (>500m)
- Anemic
- Athlete
- Lung, airways and/or sinus pathology
- Previous myocardial infarction or coronary revascularization (PCI or CABG)
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 |
|---|---|---|
| Simulated Altitude ChamberSubjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days. Measurements will be taken at sea level (baseline), during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individual's physiological baseline. On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude (intervention) chamber with altitude change of 3000 meters. At the chamber site, subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours. In the chamber, subjects will be asked to remain seated. At the completion of the chamber run, subjects will hand back the device and smartphone and complete a user experience survey. A follow up phone call to check on subjects will then be done on day 5 before closing the study. | Other | Monitoring arm |
Primary outcome
Analytical validation testing of the BA Engine's output
Time frame: Changes in subjects physiology at an altitude of 3000m compared to baseline physiology
This study aims to demonstrate that the BA Engine correctly processes monitored physiological data to generate accurate, reliable and precise detection of changes in an individual's physiology at high altitude (3000m) when compared to their baseline physiology at sea-level, as per its design specifications and to meet its intended use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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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 Simulated Altitude Chamber in people with Healthy, run by Biofourmis Singapore Pte Ltd. at 1 site in Singapore.
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 11 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: finished, as of the sponsor's last update on 16 Oct 2018. 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analytical validation testing of the BA Engine's output (time frame: Changes in subjects physiology at an altitude of 3000m compared to baseline physiology). 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 16 Oct 2018.