Oxygen SaturationNCT05784103
Comparison of Tissue Oxygenation Measurement Using Multimodal Devices
A study testing Clarifi Modulum, Perimed PeriFlux 5000 and Apple Watch Oxygen Sensor in people with Oxygen Saturation, run by Indiana University at 2 sites in United States.
Trial summary
Pulse oximeters are common medical devices used to measure blood oxygen saturation (SpO2). These devices are either stand-alone or integrated into physiologic monitoring systems, using 2 wavelengths of light to determine SpO2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Clarifi Modulum, Perimed PeriFlux 5000 and Apple Watch Oxygen Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2022to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Able to understand and complete the Informed Consent
- Both males and females
- Age between 18-65 years
- All ethnic backgrounds
Who cannot join
- Patients or limited health conditions
- Smoking tobacco product
- Prisoners
- Cannot consent for themselves
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University, School of Medicine
Indianapolis, Indiana, 15219/46202
Surya C. Gnyawali, University of Pittsburgh, UPMC
Pittsburgh, Pennsylvania, 15227
About this study
Official title: Measurement of Oxygen Saturation in Healthy Human Volunteers Before, During, and After Hyperemic Events Using Multi-Modal Techniques: Spatial Frequency Domain Imaging, Transcutaneous Oxygen Measurement, Pulse Oximeter, and Apple Watch
Pulse oximeters are common medical devices used to measure blood oxygen saturation (SpO2). These devices are either stand-alone or integrated into physiologic monitoring systems, using 2 wavelengths of light to determine SpO2. With recent advances in technology, Spatial Frequency Domain Imaging (SFDI) uses a range of light wavelengths from red to near-infrared (NIR), and smartphones such as Apple Watch, and transcutaneous oximetry TCOM now have pulse oximetry capabilities. Since it is possible that most patients could utilize this technology, we sought to assess the accuracy, reliability, and usability of these oximeters and compare outcomes. In this study, a cohort of 20 healthy volunteers above the age of 18 including males and females of different skin colors will be assessed at the same site and data will be compared. We aim to provide a set of data that will support the clinical and scientific community and identify more than one reliable skin oxygen measurement modality.
Read the detailed description
The subjects will go through a questionnaire session about their medical history by a designated study team member. The questionnaire data will be placed in RedCap using a subject ID that cannot be linked back to the subject. Then the subject will consent and be enrolled. Then the non-invasive data-collecting procedure will start on the following equipment.
Spatial Frequency Domain Imaging (SFDI): During the consenting period, the Modulim equipment will be calibrated and set up ready for scanning. The subject's volar aspect of the thumb along with the palm surface will be ready to target the optical camera head. Actual scanning takes less than 60 seconds. The images will be processed offline. During processing 3-5 different regions of interest (ROI) will be taken to measure the oxygen parameters such as tissue oxygen saturation (StO2), oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR), superficial hemoglobin (HbT1, sub-surface hemoglobin (HbT2). The model used is a Clarifi Modulim Transcutaneous oxygen monitoring (TCOM): Transcutaneous oxygen monitoring (TCOM or TcpO2) is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative and measures oxygen delivery to the skin from underlying tissue. Before positioning the electrode, an adhesive fixation ring will be placed on the dry skin on the volar aspect of the thumb and an electrolyte as a contact liquid will be filled in half and the probe is aligned into it by rotating clockwise to fasten it. The recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The model used is a Perimed PeriFlux 5000. The probe will be heated to about 45 degrees C. Although this device has other options, only the measurement of O2 will be performed using this device.
Apple Watch Oxygen Sensor: Smartwatch blood oxygen sensors also measure blood oxygen levels in the tissue. Apple Watch Series 6 introduced this new feature for monitoring blood oxygen levels using light-emitting diodes (LEDs) at the back of apple watches. A low blood oxygen level can be indicative of a serious health issue that needs immediate attention. The apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist, with photodiodes measuring the amount of light reflected back. Apple's algorithms use this information to calculate the color of the blood, which is an indication of how much oxygen is in the blood. Bright red blood is well-oxygenated, while darker blood has less oxygen. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. The apple watch sensor will be positioned on the user's preferred wrist.
Pulse Oximeter for Oxygen Monitoring: The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood (StO2). Pulse oximetry is so widely prevalent in medical care that it is often regarded as a fifth vital sign[3]. It is important to understand how the technology functions as well as its limitations. To recognize the settings in which pulse oximeter readings of oxygen saturation (SpO2), an understanding of two basic principles of pulse oximetry is required: (i) how oxyhemoglobin (HbO2) is distinguished from deoxyhemoglobin (HbR) and (ii) how the SpO2 is calculated only from the arterial compartment of blood. Pulse oximetry is based on the principle that HbO2 and HbR differentially absorb red and near-infrared (IR) light. It is fortuitous that HbO2 and HbR have significant differences in absorption at red and near-IR light because these two wavelengths penetrate tissues well whereas blue, green, yellow, and far-IR light are significantly absorbed by non-vascular tissues and water [3]. HbO2 absorbs greater amounts of IR light and lower amounts of red light than does HbR; this is consistent with experience - well-oxygenated blood with its higher concentrations of HbO2 appears bright red to the eye because it scatters more red light than does HbR. On the other hand, HHR absorbs more red light and appears less red. Exploiting this difference in light absorption properties between HbO2 and HbR, pulse oximeters emit two wavelengths of light, red at 660 nm and near-IR at 940 nm from a pair of small light-emitting diodes located in one arm of the finger probe. The light that is transmitted through the finger is then detected by a photodiode on the opposite arm of the probe. In this study, the volar aspect of the thumb and index finger of the subject will be used to measure SpO2.
- Conditions
- Oxygen Saturation
- Being tested
- Clarifi Modulum, Perimed PeriFlux 5000, Apple Watch Oxygen Sensor, Innovo iP 900AP
- Keywords
- SFDI, oxygenation, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarifi ModulumDevice
Also called Spatial Frequency Domain Imaging (SFDI)
During consenting period, the Modulim equipment will be calibrated and setup ready for scanning. Subject's volar aspect of the thumb along with the palm surface will be ready to target the optical camera head. Actual scanning takes less than 60 seconds. The images will be processed offline. During processing 3-5 different regions of interest will be taken to measure the oxygen parameters such as tissue oxygen saturation, oxy-hemoglobin, deoxy-hemoglobin, superficial hemoglobin, and sub-surface hemoglobin.
Perimed PeriFlux 5000Device
Also called Transcutaneous oxygen monitoring (TCOM)
Transcutaneous oxygen monitoring (TCOM or TcpO2) is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative, and measures oxygen delivery to the skin from underlying tissue. Before positioning the electrode, an adhesive fixation ring will be placed on the dry skin on the volar aspect of the thumb and an electrolyte as a contact liquid will be filled half and the probe is aligned into it by rotating clock-wise to fasten it. Recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The probe will be heated to about 45oC. Although this device has other options, only the measurement of O2 will be performed using this device.
Apple Watch Oxygen SensorDevice
The apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist, with photodiodes measuring the amount of light reflected back. Apple's algorithms use this information to calculate the color of the blood, which is an indication of how much oxygen is in the blood. Bright red blood is well oxygenated, while darker blood has less oxygen. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. The apple watch sensor will be positioned on the user's preferred wrist.
Innovo iP 900APDevice
Also called Pulse Oximeter
The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood. In this study, volar aspect of thumb and index finder of the subject will be used to measure blood oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Modal Measurement of Oxygen Saturation | Other | During a single study visit, participants will have oxygen saturation measured with a number of oximetry devices including Spatial Frequency Domain Imaging (SFDI), Transcutaneous oxygen monitoring (TCOM), an Apple Watch Oxygen Sensor, and a Pulse Oximeter. Each device will be used to measure oxygen saturation of the thumb and index fingers at rest, during occlusion of blood flow to the arm (using an inflated blood pressure cuff applied to the arm), and during the hyperemic post-occlusion period. Completion of all planned interventions may take up to 2 hours on the study visit day. Receives: Device: Clarifi Modulum; Device: Perimed PeriFlux 5000; Device: Apple Watch Oxygen Sensor; Device: Innovo iP 900AP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-wise Comparison of Tissue Oxygenation Measurement
4 devices used to measures the tissue oxygen saturation on healthy human volunteers
Measured: Visit 1, up to 2 hours in duration
Male vs Female Comparison of Tissue Oxygenation Measurement
Goal is to see if there is a variation in the gender biased. The criteria for the male vs female comparison were considered to find better or worse outcomes.
Measured: 1 visit, 2hrs
Skin Type Based Comparison of Tissue Oxygenation
Fitzpatrick chart-based skin categorization of the skin type. The criteria for the Fitzpatrick Skin Type grades IV, II \& III were matched with Fitzpatric table and grades were considered to find better or worse outcomes.
Please Note: The skin type analysis was performed irrespective to the devices. Only skin types were considered. So, there is no need of adding arms/groups other than the (1) Skin type IV and (2) the skin type II\& III.
Measured: 1 visit, 2hrs duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start9 Mar 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surya Gnyawali, Indiana University
- Investigators
- Surya C. Gnyawali, PhD, Principal investigator, University of Pittsburgh and Indiana University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784103
- Sponsor's protocol ID
- 13895
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2023
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Through Publication
Publications
Jones MD, Taylor JL, Barry BK. Occlusion of blood flow attenuates exercise-induced hypoalgesia in the occluded limb of healthy adults. J Appl Physiol (1985). 2017 May 1;122(5):1284-1291. doi: 10.1152/japplphysiol.01004.2016. Epub 2017 Feb 9.
PubMed 28183823El Masry M, Li R, Balasubramani GK, Roy S, Sen CK, Gnyawali SC. Comparative assessment of healthy tissue oxygenation using near-infrared imaging, transcutaneous oxygen measurement, and plethysmography. Sci Rep. 2025 Aug 19;15(1):30424. doi: 10.1038/s41598-025-15767-2.
PubMed 40830190
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Oxygen Saturation in Healthy Human Volunteers Before, During, and After Hyperemic Events Using Multi-Modal Techniques: Spatial Frequency Domain Imaging, Transcutaneous Oxygen Measurement, Pulse Oximeter, and Apple Watch
- ClinicalTrials.gov ID
- NCT05784103
- Acronym / sponsor ID
- 13895
- Conditions
- Oxygen Saturation
- Keywords
- SFDI, oxygenation, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulse oximeters are common medical devices used to measure blood oxygen saturation (SpO2). These devices are either stand-alone or integrated into physiologic monitoring systems, using 2 wavelengths of light to determine SpO2. With recent advances in technology, Spatial Frequency Domain Imaging (SFDI) uses a range of light wavelengths from red to near-infrared (NIR), and smartphones such as Apple Watch, and transcutaneous oximetry TCOM now have pulse oximetry capabilities. Since it is possible that most patients could utilize this technology, we sought to assess the accuracy, reliability, and usability of these oximeters and compare outcomes. In this study, a cohort of 20 healthy volunteers above the age of 18 including males and females of different skin colors will be assessed at the same site and data will be compared. We aim to provide a set of data that will support the clinical and scientific community and identify more than one reliable skin oxygen measurement modality.
Detailed description
The subjects will go through a questionnaire session about their medical history by a designated study team member. The questionnaire data will be placed in RedCap using a subject ID that cannot be linked back to the subject. Then the subject will consent and be enrolled. Then the non-invasive data-collecting procedure will start on the following equipment.
Spatial Frequency Domain Imaging (SFDI): During the consenting period, the Modulim equipment will be calibrated and set up ready for scanning. The subject's volar aspect of the thumb along with the palm surface will be ready to target the optical camera head. Actual scanning takes less than 60 seconds. The images will be processed offline. During processing 3-5 different regions of interest (ROI) will be taken to measure the oxygen parameters such as tissue oxygen saturation (StO2), oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR), superficial hemoglobin (HbT1, sub-surface hemoglobin (HbT2). The model used is a Clarifi Modulim Transcutaneous oxygen monitoring (TCOM): Transcutaneous oxygen monitoring (TCOM or TcpO2) is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative and measures oxygen delivery to the skin from underlying tissue. Before positioning the electrode, an adhesive fixation ring will be placed on the dry skin on the volar aspect of the thumb and an electrolyte as a contact liquid will be filled in half and the probe is aligned into it by rotating clockwise to fasten it. The recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The model used is a Perimed PeriFlux 5000. The probe will be heated to about 45 degrees C. Although this device has other options, only the measurement of O2 will be performed using this device.
Apple Watch Oxygen Sensor: Smartwatch blood oxygen sensors also measure blood oxygen levels in the tissue. Apple Watch Series 6 introduced this new feature for monitoring blood oxygen levels using light-emitting diodes (LEDs) at the back of apple watches. A low blood oxygen level can be indicative of a serious health issue that needs immediate attention. The apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist, with photodiodes measuring the amount of light reflected back. Apple's algorithms use this information to calculate the color of the blood, which is an indication of how much oxygen is in the blood. Bright red blood is well-oxygenated, while darker blood has less oxygen. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. The apple watch sensor will be positioned on the user's preferred wrist.
Pulse Oximeter for Oxygen Monitoring: The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood (StO2). Pulse oximetry is so widely prevalent in medical care that it is often regarded as a fifth vital sign[3]. It is important to understand how the technology functions as well as its limitations. To recognize the settings in which pulse oximeter readings of oxygen saturation (SpO2), an understanding of two basic principles of pulse oximetry is required: (i) how oxyhemoglobin (HbO2) is distinguished from deoxyhemoglobin (HbR) and (ii) how the SpO2 is calculated only from the arterial compartment of blood. Pulse oximetry is based on the principle that HbO2 and HbR differentially absorb red and near-infrared (IR) light. It is fortuitous that HbO2 and HbR have significant differences in absorption at red and near-IR light because these two wavelengths penetrate tissues well whereas blue, green, yellow, and far-IR light are significantly absorbed by non-vascular tissues and water [3]. HbO2 absorbs greater amounts of IR light and lower amounts of red light than does HbR; this is consistent with experience - well-oxygenated blood with its higher concentrations of HbO2 appears bright red to the eye because it scatters more red light than does HbR. On the other hand, HHR absorbs more red light and appears less red. Exploiting this difference in light absorption properties between HbO2 and HbR, pulse oximeters emit two wavelengths of light, red at 660 nm and near-IR at 940 nm from a pair of small light-emitting diodes located in one arm of the finger probe. The light that is transmitted through the finger is then detected by a photodiode on the opposite arm of the probe. In this study, the volar aspect of the thumb and index finger of the subject will be used to measure SpO2.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal Measurement of Oxygen Saturation | Other | Device: Clarifi Modulum, Device: Perimed PeriFlux 5000, Device: Apple Watch Oxygen Sensor, Device: Innovo iP 900APDuring a single study visit, participants will have oxygen saturation measured with a number of oximetry devices including Spatial Frequency Domain Imaging (SFDI), Transcutaneous oxygen monitoring (TCOM), an Apple Watch Oxygen Sensor, and a Pulse Oximeter. Each device will be used to measure oxygen saturation of the thumb and index fingers at rest, during occlusion of blood flow to the arm (using an inflated blood pressure cuff applied to the arm), and during the hyperemic post-occlusion period. Completion of all planned interventions may take up to 2 hours on the study visit day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers
- Able to understand and complete the Informed Consent
- Both males and females
- Age between 18-65 years
- All ethnic backgrounds
Key exclusion criteria (4 listed)
- Patients or limited health conditions
- Smoking tobacco product
- Prisoners
- Cannot consent for themselves
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 |
|---|---|---|
| Clarifi ModulumAlso: Spatial Frequency Domain Imaging (SFDI)During consenting period, the Modulim equipment will be calibrated and setup ready for scanning. Subject's volar aspect of the thumb along with the palm surface will be ready to target the optical camera head. Actual scanning takes less than 60 seconds. The images will be processed offline. During processing 3-5 different regions of interest will be taken to measure the oxygen parameters such as tissue oxygen saturation, oxy-hemoglobin, deoxy-hemoglobin, superficial hemoglobin, and sub-surface hemoglobin. | Device | Multi-Modal Measurement of Oxygen Saturation |
| Perimed PeriFlux 5000Also: Transcutaneous oxygen monitoring (TCOM)Transcutaneous oxygen monitoring (TCOM or TcpO2) is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative, and measures oxygen delivery to the skin from underlying tissue. Before positioning the electrode, an adhesive fixation ring will be placed on the dry skin on the volar aspect of the thumb and an electrolyte as a contact liquid will be filled half and the probe is aligned into it by rotating clock-wise to fasten it. Recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The probe will be heated to about 45oC. Although this device has other options, only the measurement of O2 will be performed using this device. | Device | Multi-Modal Measurement of Oxygen Saturation |
| Apple Watch Oxygen SensorThe apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist, with photodiodes measuring the amount of light reflected back. Apple's algorithms use this information to calculate the color of the blood, which is an indication of how much oxygen is in the blood. Bright red blood is well oxygenated, while darker blood has less oxygen. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. The apple watch sensor will be positioned on the user's preferred wrist. | Device | Multi-Modal Measurement of Oxygen Saturation |
| Innovo iP 900APAlso: Pulse OximeterThe pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood. In this study, volar aspect of thumb and index finder of the subject will be used to measure blood oxygen saturation. | Device | Multi-Modal Measurement of Oxygen Saturation |
Primary outcome
Device-wise Comparison of Tissue Oxygenation Measurement
Time frame: Visit 1, up to 2 hours in duration
4 devices used to measures the tissue oxygen saturation on healthy human volunteers
Male vs Female Comparison of Tissue Oxygenation Measurement
Time frame: 1 visit, 2hrs
Goal is to see if there is a variation in the gender biased. The criteria for the male vs female comparison were considered to find better or worse outcomes.
Skin Type Based Comparison of Tissue Oxygenation
Time frame: 1 visit, 2hrs duration
Fitzpatrick chart-based skin categorization of the skin type. The criteria for the Fitzpatrick Skin Type grades IV, II \& III were matched with Fitzpatric table and grades were considered to find better or worse outcomes. Please Note: The skin type analysis was performed irrespective to the devices. Only skin types were considered. So, there is no need of adding arms/groups other than the (1) Skin type IV and (2) the skin type II\& III.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28183823Jones MD, Taylor JL, Barry BK. Occlusion of blood flow attenuates exercise-induced hypoalgesia in the occluded limb of healthy adults. J Appl Physiol (1985). 2017 May 1;122(5):1284-1291. doi: 10.1152/japplphysiol.01004.2016. Epub 2017 Feb 9.
- Derived from this study: PubMed 40830190El Masry M, Li R, Balasubramani GK, Roy S, Sen CK, Gnyawali SC. Comparative assessment of healthy tissue oxygenation using near-infrared imaging, transcutaneous oxygen measurement, and plethysmography. Sci Rep. 2025 Aug 19;15(1):30424. doi: 10.1038/s41598-025-15767-2.
- Individual participant dataSharing planned: No. Through Publication
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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.
Surya C. Gnyawali, PhD principal investigator
University of Pittsburgh and Indiana University, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarifi Modulum, Perimed PeriFlux 5000 and Apple Watch Oxygen Sensor in people with Oxygen Saturation, run by Indiana University at 2 sites 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 5 inclusion and 4 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device-wise Comparison of Tissue Oxygenation Measurement (time frame: Visit 1, up to 2 hours in duration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784103, which also lists 2 linked publications.
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 Nov 2023.