Recruiting

Observational Study

Sponsor:

Perin Health Devices

Code:

NCT06680700

Conditions

Oxygen Saturation Measurement

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Perin Health Patch

Study Details

Brief summary:

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

Study ID

NCT06680700

Start date

Oct 21, 2024

Status verified date

Nov, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers

Healthy adult volunteers aged 18-50, who meet strict inclusion criteria to ensure safety and consistency in the results. Participants must be in good general health, with no history of respiratory, cardiovascular, or other systemic diseases that could pose additional risks during controlled desaturation. All participants are fully vaccinated for COVID-19, fluent in English, and capable of understanding and complying with the study procedures.

Interventions

Perin Health Patch

The Perin Health Patch (PHP) is a non-invasive, chest-worn device designed to monitor blood oxygen saturation (SpO2) and additional vital signs, including heart rate, respiratory rate, ECG, and bioimpedance (BioZ). Unlike traditional fingertip pulse oximeters, the PHP integrates multi-wavelength photoplethysmography (PPG) sensors with ECG and BioZ technology, allowing for continuous SpO2 tracking even during movement and daily activities.

Primary outcome measure

  • Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter [ Time Frame: Immediately after the intervention ]

Central Contacts and Locations

Central contacts

Ian McLane, Ph.D.

310-997-8176clinicalstudies@phasemargin.com

Locations

Perin Health Devices

Recruiting

Woodland Hills, California, United States, 91364

Contacts

Chief Technology Officer

310-997-8176clinicalstudies@phasemargin.com

More Information

Sponsor

Perin Health Devices

Last update posted

Nov 8, 2024

Last verified

Nov, 2024

Keywords

  • Pulse Oximeter
  • Oxygen Saturation
  • Wearable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Perin Health Devices on 2024-11-08.