A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application

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.

Conditions

• Vital Signs

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• University of Portsmouth

  collaborator OTHER

• Xim Limited

  lead INDUSTRY

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-29

Primary Completion

2021-05-01

Completion

2021-05-01

Countries

• United Kingdom

Study Locations