Oxygen Saturation MeasurementNCT06680700
Controlled Desaturation Study for Perin Health Patch Validation
An observational study of Oxygen Saturation Measurement, run by Perin Health Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation Measurement
- What is being tested?
- Perin Health Patch
- Type of treatment
- Vaccines, Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 recruited from the general community surrounding Woodland Hills, CA. The population is selected to ensure a controlled environment with minimal health variability, allowing for a precise assessment of the Perin Health Patch's performance in measuring blood oxygen saturation (SpO2) and other physiological metrics under controlled conditions of hypoxemia. All participants will be screened for general health and suitability to participate in a desaturation study, ensuring a homogenous, low-risk sample for accurate device validation.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Perin Health Devices
Woodland Hills, California, 91364
Chief Technology Officer, 310-997-8176, clinicalstudies@phasemargin.com
About this study
Official title: Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation
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.
Read the detailed description
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.
- Conditions
- Oxygen Saturation Measurement
- Being tested
- Perin Health Patch
- Keywords
- Pulse Oximeter, Oxygen Saturation, Wearable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perin Health PatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perin Health Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter
The primary outcome measure is the accuracy of blood oxygen saturation (SpO2) readings from the Perin Health Patch (PHP) in comparison to those from a reference pulse oximeter. Accuracy will be determined by calculating the mean difference (bias) and standard deviation of differences (precision) between the SpO2 measurements obtained from the PHP and those from the reference devices across a range of hypoxemic conditions (70-100% SpO2).
The PHP's SpO2 accuracy will be assessed using a root-mean-square difference (ARMS) in accordance with ISO 80601-2-61 standards, with a target ARMS of ≤ 4.0% SpO2 across the specified range.
Measured: Immediately after the intervention
Secondary outcomes (1)
SpO2 Accuracy During Motion
This outcome measures the accuracy of SpO2 readings from the PHP compared to a reference pulse oximeter while participants are in motion (e.g., walking on a treadmill). It specifically assesses if movement impacts the PHP's ability to maintain SpO2 accuracy within ISO 80601-2-61 standards, with a target ARMS of ≤ 4.0% SpO2.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Saturation MeasurementStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian M McLane, Ph.D., Principal investigator, Perin Health Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680700
- Sponsor's protocol ID
- PHD-004-24
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD), including de-identified datasets and a data dictionary describing collected variables, will be made available to other researchers following the completion of the study. The data will be shared in a way that maintains participant confidentiality and complies with ethical and legal standards. Access to IPD will be granted upon reasonable request and for use in research that aligns with the aims of the original study. Requests for IPD should be directed to the Principal Investigator, and access will be provided through a secure data-sharing platform after an approval process.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation
- ClinicalTrials.gov ID
- NCT06680700
- Acronym / sponsor ID
- PHD-004-24
- Conditions
- Oxygen Saturation Measurement
- Keywords
- Pulse Oximeter, Oxygen Saturation, Wearable
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Perin Health PatchHealthy 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. |
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 recruited from the general community surrounding Woodland Hills, CA. The population is selected to ensure a controlled environment with minimal health variability, allowing for a precise assessment of the Perin Health Patch's performance in measuring blood oxygen saturation (SpO2) and other physiological metrics under controlled conditions of hypoxemia. All participants will be screened for general health and suitability to participate in a desaturation study, ensuring a homogenous, low-risk sample for accurate device validation.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| Perin Health PatchThe 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. | Device | Healthy volunteers |
Primary outcome
Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter
Time frame: Immediately after the intervention
The primary outcome measure is the accuracy of blood oxygen saturation (SpO2) readings from the Perin Health Patch (PHP) in comparison to those from a reference pulse oximeter. Accuracy will be determined by calculating the mean difference (bias) and standard deviation of differences (precision) between the SpO2 measurements obtained from the PHP and those from the reference devices across a range of hypoxemic conditions (70-100% SpO2). The PHP's SpO2 accuracy will be assessed using a root-mean-square difference (ARMS) in accordance with ISO 80601-2-61 standards, with a target ARMS of ≤ 4.0% SpO2 across the specified range.
1 secondary outcome
SpO2 Accuracy During Motion
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD), including de-identified datasets and a data dictionary describing collected variables, will be made available to other researchers following the completion of the study. The data will be shared in a way that maintains participant confidentiality and complies with ethical and legal standards. Access to IPD will be granted upon reasonable request and for use in research that aligns with the aims of the original study. Requests for IPD should be directed to the Principal Investigator, and access will be provided through a secure data-sharing platform after an approval process.
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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.
Ian M McLane, Ph.D. principal investigator
Perin Health Devices
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 Oxygen Saturation Measurement, 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 6 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian McLane, Ph.D. (310-997-8176, clinicalstudies@phasemargin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter (time frame: Immediately after the intervention). 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 8 Nov 2024.