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

CompletedOBSERVATIONAL
Enrollment

85

Participants

Timeline

Start Date

April 29, 2019

Primary Completion Date

May 1, 2021

Study Completion Date

May 1, 2021

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."

Trial Locations (1)

PO1 2HY

University of Portsmouth, Department of Sport and Exercise Science, Portsmouth

All Listed Sponsors
collaborator

University of Portsmouth

OTHER

lead

Xim Limited

INDUSTRY

NCT03998098 - A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | Biotech Hunter | Biotech Hunter