Clinical trial NCT03998098: A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
Official title: A Single-Center Study To Demonstrate the Safety and Performance of Lifelight® First Software Application - A Non-invasive Vital Signs Monitoring Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Signs
Keywords: Blood Pressure
SPO2
Oxygen Saturation
Respiratory Rate
Pulse
Breathing Rate
Heart Rate
Lead sponsor: Xim Limited
Sponsor class: INDUSTRY
Collaborators: name: University of Portsmouth
First posted: 2019-06-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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
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:

1. Subject cannot expose their face fully for a reading to be taken
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

Primary outcomes:
measure: Blood Pressure Readings Validation
timeFrame: Single Visit; up to one day
measure: Oxygen Saturation Readings Validation
timeFrame: Single Visit; up to one day
measure: Heart Rate (pulse) Readings Validation
timeFrame: Single Visit; up to one day
measure: Respiratory Rate Readings Validation
timeFrame: Single Visit; up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: University of Portsmouth, Department of Sport and Exercise Science
state: England
Study officials:
References: