A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
NCT ID: NCT03998098
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2019-04-29
2021-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oxygen Saturation (Oximetry)
Arm to determine the performance of the Oxygen Saturation measurement in LifeLight First
Oxygen Saturation (Oximetry)
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)
Arm to determine the performance of the Heart Rate measurement in LifeLight First
Heart Rate (Pulse)
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 Rate
Arm to determine the performance of the Respiratory Rate measurement in LifeLight First
Respiratory Rate
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 Pressure
Arm to determine the performance of the Blood Pressure measurement in LifeLight First
Blood Pressure
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.
Interventions
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Oxygen Saturation (Oximetry)
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)
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 Rate
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 Pressure
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥18 years of age
3. 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)
4. 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).
Exclusion Criteria
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take part
18 Years
ALL
Yes
Sponsors
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University of Portsmouth
OTHER
Xim Limited
INDUSTRY
Responsible Party
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Locations
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University of Portsmouth, Department of Sport and Exercise Science
Portsmouth, England, United Kingdom
Countries
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Other Identifiers
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X4
Identifier Type: -
Identifier Source: org_study_id
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