Beddr Sleep SpO2 Equivalency Calibration Study

Hancock Medical, Inc.1 site in 1 country15 target enrollmentJuly 30, 2018

ConditionsOximetry

Overview

Accuracy performance of Beddr oximeter

This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.

Registry

clinicaltrials.gov

Start Date

July 30, 2018

End Date

August 3, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Sponsor

Hancock Medical, Inc.

Responsible Party

Sponsor

•Subject must have the ability to understand and provide written informed consent
•Adult subjects 18 up to 50 years of age
•Subject must be willing and able to comply with study procedures and duration
•Subject is a non-smoker or who has not smoked within 2 days prior to the study.
•Male or female of any race
•Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

•Subject is considered as being morbidly obese (defined as BMI \>39.5)
•Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
•Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
•Subjects with known respiratory conditions such as:
•uncontrolled / severe asthma,
•pneumonia / bronchitis,
•shortness of breath / respiratory distress,
•unresolved respiratory or lung surgery with continued indications of health issues,
•emphysema, COPD, lung disease
•Subjects with known heart or cardiovascular conditions such as: