Respiration RateNCT07147907
Respiratory Rate Validation Study
An observational study of Respiration Rate and Monitoring, Physiologic, run by Perin Health Devices at 1 site in United States.
Trial summary
The goal of this clinical trial is to test how accurately a new chest-worn device called the Perin Health Patch measures breathing rate in adults aged 22 and older. The main question it aims to answer is: How accurately does the Perin Health Patch measure breathing rate compared to a standard medical device that… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiration Rate, Monitoring, Physiologic
- What is being tested?
- Chest Worn Respiratory Rate Monitor
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 22 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of a minimum of 35 adult participants and maximum of 80 adult participants, ages 22 years and older. The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute certain proportions of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, Diabetes and Obesity). An attempt will be made to enroll a variety of skin tones. The participants must understand the study and consent to participate by signing the Informed Consent Form. Participant enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the participant and data demographics needed for the study.
Who may be able to join
- Participant must have the ability to understand and provide written informed consent.
- Participants or legally authorized representative must be able to read or write in English.
- Participant is adult, ages 22 years or older.
- Participant must be willing and able to comply with study procedures and duration.
Who cannot join
- Participant unwilling or unable to provide written informed consent.
- Participants evaluated by the Investigator and/or Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in Health Assessment Form and Health Screening.
- Compromised circulation, injury, or physical malformation of the fingers, toes, hands, ears or forehead/skull or other sensor ROI, which would limit the ability to test ROI.
- Tattoos in the optical path, which would limit the ability to test ROI. Certain malformations may still allow participants to participate if the condition is noted and would not affect the ROI.
- Participants with severe contact allergies to standard adhesives, latex, or other materials found in pulse oximeters, ECG electrodes, or other medical sensors (self-reported).
- Any other known health conditions may be evaluated and should be considered upon disclosure in health assessment form.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test how accurately a new chest-worn device called the Perin Health Patch measures breathing rate in adults aged 22 and older. The main question it aims to answer is:
How accurately does the Perin Health Patch measure breathing rate compared to a standard medical device that measures carbon dioxide in exhaled breath?
Read more
Participants will:
- Wear the Perin Health Patch on their chest during the study session
- Breathe through a mouthpiece or nose tube connected to a standard breathing monitor
- Follow guided breathing exercises at different speeds (from very slow to fast breathing) using a breathing app
- Sit and lie down in different positions during the measurements
- Complete the study in one visit lasting about 1-2 hours
The study will include both healthy adults and people with conditions like asthma, COPD, heart failure, diabetes, high blood pressure, or obesity to test how well the device works for different types of people. Researchers will compare the breathing rate numbers from the new chest patch to the standard medical device to see if the patch is accurate enough for medical use.
- Conditions
- Respiration Rate, Monitoring, Physiologic
- Being tested
- Chest Worn Respiratory Rate Monitor
- Keywords
- Respiratory rate validation, Breathing rate measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Worn Respiratory Rate MonitorDevice
The Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including respiratory rate and other health metrics. In this study, the device will be evaluated for its ability to accurately measure respiratory rate during controlled breathing exercises in healthy adult volunteers. The respiratory rate values recorded by the Perin Health Patch will be compared against respiratory rate measurements obtained via manually scored end tidal carbon dioxide (EtCO2) waveforms from a GE Datex-Ohmeda monitor, following Element Laboratory protocols aligned with clinical validation standards. The intervention in this study is limited to the application and use of the device for data collection during controlled respiratory rate conditions, where participants perform paced breathing exercises at various rates (5-50 breaths per minute) using a breathing app while positioned sitting or lying supine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Perin Health Patch Respiratory Rate Measurements Compared to End Tidal CO₂ Reference
The primary outcome is the accuracy of respiratory rate (RR) values reported by the Perin Health Patch compared to respiratory rate measured by manually scored end tidal carbon dioxide (EtCO₂) waveforms from a GE Datex-Ohmeda monitor. Accuracy will be assessed using mean absolute error (MAE), accuracy root mean square (ARMS), bias (mean difference), and standard deviation. Measurements will be collected during multiple stable respiratory rate plateaus (approximately 5-50 breaths per minute) achieved through paced breathing exercises. Each comparison will be made during 60-second intervals at steady-state conditions, with the reference EtCO₂ waveform scored by blinded reviewers counting respiratory peaks per minute.
Measured: During a single in-lab 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 posted29 Aug 2025
- Study start5 May 2025
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration RateStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147907
- Sponsor's protocol ID
- PR 2025-644
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Validation Study
- ClinicalTrials.gov ID
- NCT07147907
- Acronym / sponsor ID
- PR 2025-644
- Conditions
- Respiration Rate, Monitoring, Physiologic
- Keywords
- Respiratory rate validation, Breathing rate measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 29 Aug 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 test how accurately a new chest-worn device called the Perin Health Patch measures breathing rate in adults aged 22 and older. The main question it aims to answer is:
How accurately does the Perin Health Patch measure breathing rate compared to a standard medical device that measures carbon dioxide in exhaled breath?
Participants will:
- Wear the Perin Health Patch on their chest during the study session
- Breathe through a mouthpiece or nose tube connected to a standard breathing monitor
- Follow guided breathing exercises at different speeds (from very slow to fast breathing) using a breathing app
- Sit and lie down in different positions during the measurements
- Complete the study in one visit lasting about 1-2 hours
The study will include both healthy adults and people with conditions like asthma, COPD, heart failure, diabetes, high blood pressure, or obesity to test how well the device works for different types of people. Researchers will compare the breathing rate numbers from the new chest patch to the standard medical device to see if the patch is accurate enough for medical use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of a minimum of 35 adult participants and maximum of 80 adult participants, ages 22 years and older. The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute certain proportions of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, Diabetes and Obesity). An attempt will be made to enroll a variety of skin tones. The participants must understand the study and consent to participate by signing the Informed Consent Form. Participant enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the participant and data demographics needed for the study.
Key inclusion criteria (4 listed)
- Participant must have the ability to understand and provide written informed consent.
- Participants or legally authorized representative must be able to read or write in English.
- Participant is adult, ages 22 years or older.
- Participant must be willing and able to comply with study procedures and duration.
Key exclusion criteria (6 listed)
- Participant unwilling or unable to provide written informed consent.
- Participants evaluated by the Investigator and/or Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in Health Assessment Form and Health Screening.
- Compromised circulation, injury, or physical malformation of the fingers, toes, hands, ears or forehead/skull or other sensor ROI, which would limit the ability to test ROI.
- Tattoos in the optical path, which would limit the ability to test ROI. Certain malformations may still allow participants to participate if the condition is noted and would not affect the ROI.
- Participants with severe contact allergies to standard adhesives, latex, or other materials found in pulse oximeters, ECG electrodes, or other medical sensors (self-reported).
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 Respiratory Rate MonitorThe Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including respiratory rate and other health metrics. In this study, the device will be evaluated for its ability to accurately measure respiratory rate during controlled breathing exercises in healthy adult volunteers. The respiratory rate values recorded by the Perin Health Patch will be compared against respiratory rate measurements obtained via manually scored end tidal carbon dioxide (EtCO2) waveforms from a GE Datex-Ohmeda monitor, following Element Laboratory protocols aligned with clinical validation standards. The intervention in this study is limited to the application and use of the device for data collection during controlled respiratory rate conditions, where participants perform paced breathing exercises at various rates (5-50 breaths per minute) using a breathing app while positioned sitting or lying supine. | Device | – |
Primary outcome
Accuracy of Perin Health Patch Respiratory Rate Measurements Compared to End Tidal CO₂ Reference
Time frame: During a single in-lab session lasting approximately 1 hour per participant
The primary outcome is the accuracy of respiratory rate (RR) values reported by the Perin Health Patch compared to respiratory rate measured by manually scored end tidal carbon dioxide (EtCO₂) waveforms from a GE Datex-Ohmeda monitor. Accuracy will be assessed using mean absolute error (MAE), accuracy root mean square (ARMS), bias (mean difference), and standard deviation. Measurements will be collected during multiple stable respiratory rate plateaus (approximately 5-50 breaths per minute) achieved through paced breathing exercises. Each comparison will be made during 60-second intervals at steady-state conditions, with the reference EtCO₂ waveform scored by blinded reviewers counting respiratory peaks per minute.
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 29 Aug 2025.
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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. 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 Respiration Rate and Monitoring, Physiologic, 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 6 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 29 Aug 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 Respiratory Rate Measurements Compared to End Tidal CO₂ Reference (time frame: During a single in-lab 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 29 Aug 2025.