HypoxiaNCT07027150
Pulse Oximeter Validation Study for the Perin Health Patch
An observational study of Hypoxia, run by Perin Health Devices at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Chest Worn Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of healthy adult volunteers between the ages of 18 and 50 years, recruited to ensure adequate demographic and skin tone diversity. At least 15% of participants will have Fitzpatrick skin types V or VI. All participants must be in good general health, with no history of chronic cardiovascular, pulmonary, hematologic, renal, or hepatic conditions. Volunteers are excluded if they have a body mass index (BMI) greater than 30, are current smokers, or have any contraindications to arterial line placement or hypoxia exposure. Pregnant or lactating individuals are also excluded. All participants must provide informed consent and be fully vaccinated against COVID-19. The population is limited to English-speaking individuals due to current protocol constraints.
Who may be able to join
- The subject is aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English (we are actively working to expand access to this study to subjects who prefer other languages)
- The subject has provided informed consent and is willing to comply with the study procedures
Who cannot join
- The subject is obese (BMI>30).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
- The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
Show all 18Show fewer
- The subject has any other serious systemic illness.
- The subject is a current smoker.
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on an exam by the investigator (Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
- Subjects are screened for COVID 19 before coming in for testing. Fully vaccinated subjects are recruited for this study. Subjects will be asked if they have any symptoms related to COVID -19 and if they have any symptoms or are sick they cannot participate and a temperature will be taken before the study.
- The subject has recently been injected with methylene blue.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia. This study will help determine whether the device meets the performance requirements of ISO 80601-2-61 and FDA 510(k) for SpO₂ measurement accuracy.
The main questions it aims to answer is whether the Perin Health Patch meet the required accuracy performance (Arms ≤ 3.5%) across the full range of 70-100% SaO₂ as defined by ISO 80601-2-61.
Read more
Participants will be healthy adults aged 18 to 50 years old, representing a diverse range of skin tones (including ≥15% with Fitzpatrick V or VI). Inclusion criteria require general good health and no chronic medical conditions. Exclusion criteria include obesity, cardiopulmonary conditions, hemoglobinopathies, pregnancy, and other safety considerations.
Participants will:
- Undergo screening and informed consent, including skin tone assessment using colorimetry and spectrophotometry.
- Be instrumented with the Perin Health Patch and reference pulse oximeters on randomized fingers.
- Undergo placement of an arterial catheter by a trained physician.
- Be asked to breathe through a mouthpiece while inspired oxygen concentration is gradually reduced under physician control to generate multiple plateaus of hypoxemia (70-100% SaO₂).
- Provide up to 30 arterial blood samples at steady-state hypoxemia levels to determine functional SaO₂ via co-oximetry.
- Be continuously monitored for SpO₂, heart rate, ECG, respiratory rate, and blood pressure during the study.
- Return to normoxia, and have the arterial line removed with hemostasis confirmed before discharge.
This protocol, based on UCSF's standard hypoxia lab procedures, has been used in over 3000 subjects and is designed to meet or exceed requirements of ISO 80601-2-61, ISO 14155, and FDA 510(k) standards.
Read the detailed description
This study is designed to evaluate the oxygen saturation measurement performance of the Perin Health Patch, a chest-worn pulse oximeter, during controlled hypoxemia in healthy adult volunteers. The study is conducted using UCSF's standard protocol for pulse oximeter performance evaluation, which has historically informed FDA and ISO standards (including ISO 80601-2-61). The Perin Health Patch integrates photoplethysmography (PPG) and other sensing modalities into a wearable form factor intended for clinical and non-clinical monitoring settings.
Participants will be enrolled to ensure demographic diversity, including representation across a wide spectrum of skin pigmentation, with a minimum of 15% of subjects having Fitzpatrick skin type V or VI. The study will control inspired gas concentrations to induce stable arterial oxygen saturation plateaus between 70% and 100%. These plateaus enable comparison of the device's displayed SpO₂ values to gold-standard SaO₂ values determined from arterial blood samples using co-oximetry.
SpO₂ readings from the Perin Health Patch will be collected concurrently with FDA-cleared reference pulse oximeters placed on contralateral or adjacent fingers. Readings at each plateau will be compared to SaO₂ to assess device accuracy and bias across the range of hypoxemia. The study will follow ISO 80601-2-61 methodology, including at least 200 paired data points from a minimum of 10 subjects. Averaging times and perfusion indices will be documented for all devices.
Data will be analyzed to determine root mean square error (Arms), bias, and standard deviation between device SpO₂ and co-oximeter SaO₂ readings. The results will be used to assess whether the Perin Health Patch meets regulatory performance requirements for oxygen saturation monitoring and to support future regulatory submissions.
This study does not involve randomization to different treatments or control arms. All participants undergo the same measurement protocol. No investigational treatments are administered. Safety protocols, including continuous vital sign monitoring and immediate availability of emergency medical care, are employed throughout the study.
- Conditions
- Hypoxia
- Being tested
- Chest Worn Pulse Oximeter
- Keywords
- Hypoxia, Desaturation, Pulse Oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Worn Pulse OximeterDevice
The Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including photoplethysmography (PPG), oxygen saturation (SpO₂), electrocardiography (ECG), and other health metrics. In this study, the device will be evaluated for its ability to accurately measure SpO₂ during controlled hypoxemia in healthy adult volunteers. The SpO₂ values recorded by the Perin Health Patch will be compared against arterial oxygen saturation values (SaO₂) obtained via co-oximetry, following the UCSF Hypoxia Lab protocol aligned with ISO 80601-2-61 standards.
This device integrates PPG and ECG sensors into a single chest-applied unit, distinguishing it from conventional finger or earlobe pulse oximeters. The intervention in this study is limited to the application and use of the device for data collection under clinically controlled oxygen saturation conditions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | This cohort includes healthy adult volunteers aged 18-50 who undergo controlled hypoxemia testing to evaluate the performance of the Perin Health Patch, a chest-worn pulse oximeter. Each participant will be fitted with the Perin Health Patch and one or more FDA-cleared reference pulse oximeters. Under the supervision of trained clinicians, inspired oxygen concentrations will be adjusted to achieve stable oxygen saturation plateaus between 70% and 100%. Arterial blood samples will be collected and analyzed via co-oximetry to determine true functional SaO₂ values. Device performance will be assessed by comparing the SpO₂ readings from the Perin Health Patch with these reference values in accordance with ISO 80601-2-61. Receives: Device: Chest Worn Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Perin Health Patch SpO₂ Measurements Compared to Arterial Blood Gas SaO₂
The primary outcome is the accuracy of the oxygen saturation (SpO₂) values reported by the Perin Health Patch compared to functional arterial oxygen saturation (SaO₂) measured by co-oximetry from arterial blood samples. Accuracy will be assessed according to ISO 80601-2-61 standards using root-mean-square error (Arms), bias (mean difference), and standard deviation. Measurements will be collected at multiple stable plateaus of oxygen saturation induced by adjusting inspired gas concentrations in a controlled laboratory setting. Each comparison will be made at steady-state conditions, verified by reference pulse oximeters and end-tidal gas analysis.
Measured: During a single in-lab hypoxemia session lasting approximately 1 hour per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start27 May 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027150
- Sponsor's protocol ID
- PHD-25-002
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter Validation Study for the Perin Health Patch
- ClinicalTrials.gov ID
- NCT07027150
- Acronym / sponsor ID
- PHD-25-002
- Conditions
- Hypoxia
- Keywords
- Hypoxia, Desaturation, Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 27 May 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia. This study will help determine whether the device meets the performance requirements of ISO 80601-2-61 and FDA 510(k) for SpO₂ measurement accuracy.
The main questions it aims to answer is whether the Perin Health Patch meet the required accuracy performance (Arms ≤ 3.5%) across the full range of 70-100% SaO₂ as defined by ISO 80601-2-61.
Participants will be healthy adults aged 18 to 50 years old, representing a diverse range of skin tones (including ≥15% with Fitzpatrick V or VI). Inclusion criteria require general good health and no chronic medical conditions. Exclusion criteria include obesity, cardiopulmonary conditions, hemoglobinopathies, pregnancy, and other safety considerations.
Participants will:
- Undergo screening and informed consent, including skin tone assessment using colorimetry and spectrophotometry.
- Be instrumented with the Perin Health Patch and reference pulse oximeters on randomized fingers.
- Undergo placement of an arterial catheter by a trained physician.
- Be asked to breathe through a mouthpiece while inspired oxygen concentration is gradually reduced under physician control to generate multiple plateaus of hypoxemia (70-100% SaO₂).
- Provide up to 30 arterial blood samples at steady-state hypoxemia levels to determine functional SaO₂ via co-oximetry.
- Be continuously monitored for SpO₂, heart rate, ECG, respiratory rate, and blood pressure during the study.
- Return to normoxia, and have the arterial line removed with hemostasis confirmed before discharge.
This protocol, based on UCSF's standard hypoxia lab procedures, has been used in over 3000 subjects and is designed to meet or exceed requirements of ISO 80601-2-61, ISO 14155, and FDA 510(k) standards.
Detailed description
This study is designed to evaluate the oxygen saturation measurement performance of the Perin Health Patch, a chest-worn pulse oximeter, during controlled hypoxemia in healthy adult volunteers. The study is conducted using UCSF's standard protocol for pulse oximeter performance evaluation, which has historically informed FDA and ISO standards (including ISO 80601-2-61). The Perin Health Patch integrates photoplethysmography (PPG) and other sensing modalities into a wearable form factor intended for clinical and non-clinical monitoring settings.
Participants will be enrolled to ensure demographic diversity, including representation across a wide spectrum of skin pigmentation, with a minimum of 15% of subjects having Fitzpatrick skin type V or VI. The study will control inspired gas concentrations to induce stable arterial oxygen saturation plateaus between 70% and 100%. These plateaus enable comparison of the device's displayed SpO₂ values to gold-standard SaO₂ values determined from arterial blood samples using co-oximetry.
SpO₂ readings from the Perin Health Patch will be collected concurrently with FDA-cleared reference pulse oximeters placed on contralateral or adjacent fingers. Readings at each plateau will be compared to SaO₂ to assess device accuracy and bias across the range of hypoxemia. The study will follow ISO 80601-2-61 methodology, including at least 200 paired data points from a minimum of 10 subjects. Averaging times and perfusion indices will be documented for all devices.
Data will be analyzed to determine root mean square error (Arms), bias, and standard deviation between device SpO₂ and co-oximeter SaO₂ readings. The results will be used to assess whether the Perin Health Patch meets regulatory performance requirements for oxygen saturation monitoring and to support future regulatory submissions.
This study does not involve randomization to different treatments or control arms. All participants undergo the same measurement protocol. No investigational treatments are administered. Safety protocols, including continuous vital sign monitoring and immediate availability of emergency medical care, are employed throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Device: Chest Worn Pulse OximeterThis cohort includes healthy adult volunteers aged 18-50 who undergo controlled hypoxemia testing to evaluate the performance of the Perin Health Patch, a chest-worn pulse oximeter. Each participant will be fitted with the Perin Health Patch and one or more FDA-cleared reference pulse oximeters. Under the supervision of trained clinicians, inspired oxygen concentrations will be adjusted to achieve stable oxygen saturation plateaus between 70% and 100%. Arterial blood samples will be collected and analyzed via co-oximetry to determine true functional SaO₂ values. Device performance will be assessed by comparing the SpO₂ readings from the Perin Health Patch with these reference values in accordance with ISO 80601-2-61. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of healthy adult volunteers between the ages of 18 and 50 years, recruited to ensure adequate demographic and skin tone diversity. At least 15% of participants will have Fitzpatrick skin types V or VI. All participants must be in good general health, with no history of chronic cardiovascular, pulmonary, hematologic, renal, or hepatic conditions. Volunteers are excluded if they have a body mass index (BMI) greater than 30, are current smokers, or have any contraindications to arterial line placement or hypoxia exposure. Pregnant or lactating individuals are also excluded. All participants must provide informed consent and be fully vaccinated against COVID-19. The population is limited to English-speaking individuals due to current protocol constraints.
Key inclusion criteria (4 listed)
- The subject is aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English (we are actively working to expand access to this study to subjects who prefer other languages)
- The subject has provided informed consent and is willing to comply with the study procedures
Key exclusion criteria (18 listed)
- The subject is obese (BMI>30).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Worn Pulse OximeterThe Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including photoplethysmography (PPG), oxygen saturation (SpO₂), electrocardiography (ECG), and other health metrics. In this study, the device will be evaluated for its ability to accurately measure SpO₂ during controlled hypoxemia in healthy adult volunteers. The SpO₂ values recorded by the Perin Health Patch will be compared against arterial oxygen saturation values (SaO₂) obtained via co-oximetry, following the UCSF Hypoxia Lab protocol aligned with ISO 80601-2-61 standards. This device integrates PPG and ECG sensors into a single chest-applied unit, distinguishing it from conventional finger or earlobe pulse oximeters. The intervention in this study is limited to the application and use of the device for data collection under clinically controlled oxygen saturation conditions. | Device | Healthy Volunteer |
Primary outcome
Accuracy of Perin Health Patch SpO₂ Measurements Compared to Arterial Blood Gas SaO₂
Time frame: During a single in-lab hypoxemia session lasting approximately 1 hour per participant
The primary outcome is the accuracy of the oxygen saturation (SpO₂) values reported by the Perin Health Patch compared to functional arterial oxygen saturation (SaO₂) measured by co-oximetry from arterial blood samples. Accuracy will be assessed according to ISO 80601-2-61 standards using root-mean-square error (Arms), bias (mean difference), and standard deviation. Measurements will be collected at multiple stable plateaus of oxygen saturation induced by adjusting inspired gas concentrations in a controlled laboratory setting. Each comparison will be made at steady-state conditions, verified by reference pulse oximeters and end-tidal gas analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Related trials for Hypoxia
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects
Healthy Subjects (HS), Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Perin Health Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Perin Health Patch SpO₂ Measurements Compared to Arterial Blood Gas SaO₂ (time frame: During a single in-lab hypoxemia session lasting approximately 1 hour per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.