Vital SignsNCT03998098
A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
An observational study of Vital Signs, run by Xim Limited at 1 site in United Kingdom.
Trial summary
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- What is being tested?
- Oxygen Saturation (Oximetry), Heart Rate (Pulse) and Respiratory Rate
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2019to 1 May 2021
- Phase
- Observational
- 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
Study population: The inclusion/exclusion criteria is limited to the intended use of the device, therefore only individuals, of any sex, over the age of 18 will be included in the study. The individuals for the purpose of the study have to be able to perform physical activity in the form of the ergometer if they are undertaking the exercise component.
Who may be able to join
- Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
- Subject is ≥18 years of age
- Subject's health status: individual is considered to be healthy (hypertension and hypotension is permissible. Other stable diseases at the time of testing are also permissible)
- Subject is capable of undergoing controlled hypoxaemia to the levels called for the in the protocol with minimal medical risk (unless only participating in the blood pressure study).
Who cannot join
- Subject cannot expose their face fully for a reading to be taken
- Subject is unable to give informed consent
- Subject is outside of the specified age range
- Subject has already taken part in the study (all 4 sub studies)
- Subject with significant irregular heart rhythm or any disease that might affect the results of the study
- Subject is not capable of undergoing controlled hypoxia and would be placed at undue medical risk if this occurred
- Subject has any contraindications identified that would deem them unsuitable to take part
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Portsmouth, Department of Sport and Exercise Science
Portsmouth, England, PO1 2HY
About this study
Official title: A Single-Center Study To Demonstrate the Safety and Performance of Lifelight® First Software Application - A Non-invasive Vital Signs Monitoring Device
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
Read the detailed description
Assessment of vital signs is an essential part of any clinical assessment and is undertaken regularly on patients accessing healthcare services. The accuracy of these measurements is of vital importance as decisions regarding the urgency of medical review and subsequent management are often influenced by these measures.
The measurement of vital signs as part of normal medical care requires a level of medical / nursing skill or patient training. Observations can be altered by stress or anxiety making the results less representative of the patient's clinical state. This is particularly recognised in the measurement of blood pressure but stress can also alter heart and respiratory rate.
Regular community and/or home monitoring of vital signs is useful in older populations and those with long-term conditions; standard of care methods can be labour intensive for health care providers, leading to greater financial burdens for health services.
Lifelight® First is software which allows non-invasive, non-contact measurement of these observations. It can be used on a tablet (e.g. Apple® iPad®) that possesses an integral camera. The use of computer technology is now commonplace in society so the general public are likely to be accepting of this as a non-threatening method of measurement, thus reducing the impact of anxiety on the results. Lifelight® First therefore has potential application within various areas of the health care system, it could also be useful in settings where direct access to health care is limited or as a part of a telemedicine service.
This study has been designed to evaluate the safety and performance of Lifelight® First, an investigational medical device. The data will be used to support the CE marking of the Lifelight® First device. The study design has been based upon the guidance in ISO standards and also within published scientific literature. Ultimately the data points to be obtained and methodology will be required to follow this guidance in order to obtain the CE mark.
- Conditions
- Vital Signs
- Being tested
- Oxygen Saturation (Oximetry), Heart Rate (Pulse), Respiratory Rate, Blood Pressure
- Keywords
- Blood Pressure, SPO2, Oxygen Saturation, Respiratory Rate, Pulse, Breathing Rate, Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Saturation (Oximetry)Diagnostic test
Also called Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First
Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers
Heart Rate (Pulse)Diagnostic test
Also called Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First
Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers
Respiratory RateDiagnostic test
Also called Two Clinical Observers, LifeLight First
Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers
Blood PressureDiagnostic test
Also called Welch Allyn Connex Spot Monitor CSM 7500, LifeLight First
Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers For participants only participating in the Blood Pressure Arm of the trial, they will not be required to enter the normobaric chamber but will have their blood pressure readings taken in the ambient environment including lying supine in order to generate hypotensive readings.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen Saturation (Oximetry) | Arm to determine the performance of the Oxygen Saturation measurement in LifeLight First Receives: Diagnostic Test: Oxygen Saturation (Oximetry) | |
| Heart Rate (Pulse) | Arm to determine the performance of the Heart Rate measurement in LifeLight First Receives: Diagnostic Test: Heart Rate (Pulse) | |
| Respiratory Rate | Arm to determine the performance of the Respiratory Rate measurement in LifeLight First Receives: Diagnostic Test: Respiratory Rate | |
| Blood Pressure | Arm to determine the performance of the Blood Pressure measurement in LifeLight First Receives: Diagnostic Test: Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Readings Validation
Agreement of Lifelight® First standard of care and range for blood pressure as per ISO 81060-2-Non-invasive-sphygmomanometers-Part 2-Clinical validation of automated measurement type
Measured: Single Visit; up to one day
Oxygen Saturation Readings Validation
Agreement of Lifelight® First standard of care and range for oxygen saturation as per ISO 80601-2-61-Medical electrical equipment-Part 2-61:Particular requirements for basic safety and essential performance of pulse oximeter equipment
Measured: Single Visit; up to one day
Heart Rate (pulse) Readings Validation
Agreement of Lifelight® First standard of care and range for heart rate (pulse) function as per ISO 80601-2-61- Particular requirements for basic safety and essential performance of pulse oximeter equipment
Measured: Single Visit; up to one day
Respiratory Rate Readings Validation
Agreement of Lifelight® First standard of care and range for respiratory rate by manually counting chest rises.
Measured: Single Visit; up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start29 Apr 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998098
- Sponsor's protocol ID
- X4
- Status last verified
- Jul 2021
- First submitted
- 13 May 2019
- Last updated
- 26 Jul 2021
- 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 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Study To Demonstrate the Safety and Performance of Lifelight® First Software Application - A Non-invasive Vital Signs Monitoring Device
- ClinicalTrials.gov ID
- NCT03998098
- Acronym / sponsor ID
- X4
- Conditions
- Vital Signs
- Keywords
- Blood Pressure, SPO2, Oxygen Saturation, Respiratory Rate, Pulse, Breathing Rate, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Portsmouth
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Jun 2019 (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.
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
Detailed description
Assessment of vital signs is an essential part of any clinical assessment and is undertaken regularly on patients accessing healthcare services. The accuracy of these measurements is of vital importance as decisions regarding the urgency of medical review and subsequent management are often influenced by these measures.
The measurement of vital signs as part of normal medical care requires a level of medical / nursing skill or patient training. Observations can be altered by stress or anxiety making the results less representative of the patient's clinical state. This is particularly recognised in the measurement of blood pressure but stress can also alter heart and respiratory rate.
Regular community and/or home monitoring of vital signs is useful in older populations and those with long-term conditions; standard of care methods can be labour intensive for health care providers, leading to greater financial burdens for health services.
Lifelight® First is software which allows non-invasive, non-contact measurement of these observations. It can be used on a tablet (e.g. Apple® iPad®) that possesses an integral camera. The use of computer technology is now commonplace in society so the general public are likely to be accepting of this as a non-threatening method of measurement, thus reducing the impact of anxiety on the results. Lifelight® First therefore has potential application within various areas of the health care system, it could also be useful in settings where direct access to health care is limited or as a part of a telemedicine service.
This study has been designed to evaluate the safety and performance of Lifelight® First, an investigational medical device. The data will be used to support the CE marking of the Lifelight® First device. The study design has been based upon the guidance in ISO standards and also within published scientific literature. Ultimately the data points to be obtained and methodology will be required to follow this guidance in order to obtain the CE mark.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxygen Saturation (Oximetry) | – | Diagnostic Test: Oxygen Saturation (Oximetry)Arm to determine the performance of the Oxygen Saturation measurement in LifeLight First |
| Heart Rate (Pulse) | – | Diagnostic Test: Heart Rate (Pulse)Arm to determine the performance of the Heart Rate measurement in LifeLight First |
| Respiratory Rate | – | Diagnostic Test: Respiratory RateArm to determine the performance of the Respiratory Rate measurement in LifeLight First |
| Blood Pressure | – | Diagnostic Test: Blood PressureArm to determine the performance of the Blood Pressure measurement in LifeLight First |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion/exclusion criteria is limited to the intended use of the device, therefore only individuals, of any sex, over the age of 18 will be included in the study. The individuals for the purpose of the study have to be able to perform physical activity in the form of the ergometer if they are undertaking the exercise component.
Key inclusion criteria (4 listed)
- Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
- Subject is ≥18 years of age
- Subject's health status: individual is considered to be healthy (hypertension and hypotension is permissible. Other stable diseases at the time of testing are also permissible)
- Subject is capable of undergoing controlled hypoxaemia to the levels called for the in the protocol with minimal medical risk (unless only participating in the blood pressure study).
Key exclusion criteria (7 listed)
- Subject cannot expose their face fully for a reading to be taken
- Subject is unable to give informed consent
- Subject is outside of the specified age range
- Subject has already taken part in the study (all 4 sub studies)
- Subject with significant irregular heart rhythm or any disease that might affect the results of the study
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 |
|---|---|---|
| Oxygen Saturation (Oximetry)Also: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight FirstParticipants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers | Diagnostic test | Oxygen Saturation (Oximetry) |
| Heart Rate (Pulse)Also: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight FirstParticipants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers | Diagnostic test | Heart Rate (Pulse) |
| Respiratory RateAlso: Two Clinical Observers, LifeLight FirstParticipants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers | Diagnostic test | Respiratory Rate |
| Blood PressureAlso: Welch Allyn Connex Spot Monitor CSM 7500, LifeLight FirstParticipants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%. The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs. Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers For participants only participating in the Blood Pressure Arm of the trial, they will not be required to enter the normobaric chamber but will have their blood pressure readings taken in the ambient environment including lying supine in order to generate hypotensive readings. | Diagnostic test | Blood Pressure |
Primary outcome
Blood Pressure Readings Validation
Time frame: Single Visit; up to one day
Agreement of Lifelight® First standard of care and range for blood pressure as per ISO 81060-2-Non-invasive-sphygmomanometers-Part 2-Clinical validation of automated measurement type
Oxygen Saturation Readings Validation
Time frame: Single Visit; up to one day
Agreement of Lifelight® First standard of care and range for oxygen saturation as per ISO 80601-2-61-Medical electrical equipment-Part 2-61:Particular requirements for basic safety and essential performance of pulse oximeter equipment
Heart Rate (pulse) Readings Validation
Time frame: Single Visit; up to one day
Agreement of Lifelight® First standard of care and range for heart rate (pulse) function as per ISO 80601-2-61- Particular requirements for basic safety and essential performance of pulse oximeter equipment
Respiratory Rate Readings Validation
Time frame: Single Visit; up to one day
Agreement of Lifelight® First standard of care and range for respiratory rate by manually counting chest rises.
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 26 Jul 2021.
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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?
An observational study of Vital Signs, run by Xim Limited at 1 site in United Kingdom.
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 7 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 26 Jul 2021. 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 United Kingdom. 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?
Blood Pressure Readings Validation (time frame: Single Visit; up to one day). The study lists 4 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 26 Jul 2021.