Controlled Desaturation Study for Perin Health Patch Validation

Description

This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device. The PHP device uses light sensors to measure blood oxygen saturation (SpO2), similar to how standard pulse oximeters work, and could allow for continuous remote monitoring at home. Participants in this study will breathe low-oxygen air through a mask to simulate different oxygen levels in a controlled environment. The goal is to see if the PHP device can accurately measure blood oxygen levels under different conditions and meet safety standards set by the FDA and international guidelines.

Conditions

Oxygen Saturation Measurement

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Study Overview

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Study Details

Study overview

This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device. The PHP device uses light sensors to measure blood oxygen saturation (SpO2), similar to how standard pulse oximeters work, and could allow for continuous remote monitoring at home. Participants in this study will breathe low-oxygen air through a mask to simulate different oxygen levels in a controlled environment. The goal is to see if the PHP device can accurately measure blood oxygen levels under different conditions and meet safety standards set by the FDA and international guidelines.

Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

Controlled Desaturation Study for Perin Health Patch Validation

Condition
Oxygen Saturation Measurement
Intervention / Treatment

-

Contacts and Locations

Woodland Hills

Perin Health Devices, Woodland Hills, California, United States, 91364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults aged 18 years to 50 years
  • * The subject is in good general health with no evidence of any medical problems,
  • * Fully vaccinated for COVID-19
  • * Fluent in both written and spoken English
  • * Willing and able to provide informed consent,
  • * Able to comply with study procedure.
  • * Children (under the age of 18)
  • * Adults above 50 years old
  • * History of heart, lung, kidney, or liver disease.
  • * Obesity (BMI \> 30),
  • * Diagnosis of asthma, sleep apnea, or use of CPAP.
  • * Diagnosis of Raynaud's disease
  • * Unacceptable collateral circulation based on an exam by the investigator (Allen's test).
  • * Pregnant, lactating or trying to get pregnant
  • * Current smoker
  • * History of diabetes
  • * Clotting disorder
  • * Hemoglobinopathy or history of anemia
  • * History of fainting or vasovagal response
  • * Any other serious systemic illness
  • * Any other condition which, in the opinion of the investigators, would make them unsuitable for the study,
  • * Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly,
  • * Any evidence, in the opinion of the investigators, of medical problems or poor general health
  • * Any symptoms related to COVID-19
  • * No vaccinated for COVID-19
  • * Recent injection with methylene blue
  • * History of reactions to medical adhesives,
  • * Unable or unwilling to provide informed consent,
  • * Inability to comply with the study procedure,
  • * Non-English Speaker.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Perin Health Devices,

Ian M McLane, Ph.D., PRINCIPAL_INVESTIGATOR, Perin Health Devices

Study Record Dates

2025-03-31