Controlled Desaturation Study for Perin Health Patch Validation

Официальное название

Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

Обзор

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.

Подробное описание

The Perin Health Patch (PHP) is a non-invasive, chest-worn medical device that continuously measures blood oxygen saturation (SpO2), alongside other vital signs. The PHP's performance will be assessed under controlled hypoxemia (low oxygen levels), where its readings will be compared to a standard pulse oximeter validated against co-oximeter reference values.

In this single-site, prospective study, up to 25 healthy adult volunteers will undergo controlled desaturation sessions. During each session, a mask delivering a low-oxygen gas mixture will be used to safely lower participants' SpO2 levels. This method simulates a range of oxygenation states, from 70% to 100% SpO2, which is critical for testing the device's accuracy across a clinically relevant range. The PHP's readings will be captured alongside those from two standard pulse oximeters placed on both hands. Participants will be carefully monitored by clinical staff throughout the study, with emergency oxygen and other medical equipment readily available to ensure participant safety.

Participants will complete two desaturation "runs," each lasting approximately 10-15 minutes, with brief breaks between sessions. During some sessions, participants may be asked to walk slowly on a treadmill to simulate movement conditions. This study design aligns with the ISO 80601-2-61 standard, supporting robust accuracy assessments under both stationary and motion conditions.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• SpO2 Accuracy During Motion [Срок оценки: Immediately after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Perin Health Devices — Woodland Hills

Идентификаторы

NCT: NCT06680700 · PHD-004-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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