NCT06680700 Controlled Desaturation Study for Perin Health Patch Validation
| NCT ID | NCT06680700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Perin Health Devices |
| Condition | Oxygen Saturation Measurement |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-10-21 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ian M McLane, Ph.D.
PRINCIPAL INVESTIGATOR
Perin Health Devices
Frequently Asked Questions
Who can join the NCT06680700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Oxygen Saturation Measurement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06680700 currently recruiting?
Yes, NCT06680700 is actively recruiting participants. Contact the research team at clinicalstudies@phasemargin.com for enrollment information.
Where is the NCT06680700 trial being conducted?
This trial is being conducted at Woodland Hills, United States.
Who is sponsoring the NCT06680700 clinical trial?
NCT06680700 is sponsored by Perin Health Devices. The principal investigator is Ian M McLane, Ph.D. at Perin Health Devices. The trial plans to enroll 25 participants.