RECRUITING

Controlled Desaturation Study for Perin Health Patch Validation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

Quick Facts

Study Start:2024-10-21
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06680700

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 years to 50 years
  2. * The subject is in good general health with no evidence of any medical problems,
  3. * Fully vaccinated for COVID-19
  4. * Fluent in both written and spoken English
  5. * Willing and able to provide informed consent,
  6. * Able to comply with study procedure.
  1. * Children (under the age of 18)
  2. * Adults above 50 years old
  3. * History of heart, lung, kidney, or liver disease.
  4. * Obesity (BMI \> 30),
  5. * Diagnosis of asthma, sleep apnea, or use of CPAP.
  6. * Diagnosis of Raynaud's disease
  7. * Unacceptable collateral circulation based on an exam by the investigator (Allen's test).
  8. * Pregnant, lactating or trying to get pregnant
  9. * Current smoker
  10. * History of diabetes
  11. * Clotting disorder
  12. * Hemoglobinopathy or history of anemia
  13. * History of fainting or vasovagal response
  14. * Any other serious systemic illness
  15. * Any other condition which, in the opinion of the investigators, would make them unsuitable for the study,
  16. * Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly,
  17. * Any evidence, in the opinion of the investigators, of medical problems or poor general health
  18. * Any symptoms related to COVID-19
  19. * No vaccinated for COVID-19
  20. * Recent injection with methylene blue
  21. * History of reactions to medical adhesives,
  22. * Unable or unwilling to provide informed consent,
  23. * Inability to comply with the study procedure,
  24. * Non-English Speaker.

Contacts and Locations

Study Contact

Ian McLane, Ph.D.
CONTACT
310-997-8176
clinicalstudies@phasemargin.com

Principal Investigator

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

Study Locations (Sites)

Perin Health Devices
Woodland Hills, California, 91364
United States

Collaborators and Investigators

Sponsor: Perin Health Devices

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Pulse Oximeter
  • Oxygen Saturation
  • Wearable

Additional Relevant MeSH Terms

  • Oxygen Saturation Measurement