HealthyMRT01NCT02527070
Evaluating the State of Microvessels by Minimum Rise Time (MRT01)
A study testing RESPeRATE (Paced Breathing), Quantum Warp10 (Red LED) and Omnilux new-U (Near Infrared LED) in people with Healthy, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
Trial summary
Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. The objective of the current study is to investigate a potential relationship between MRT (minimum rise time, in time units) a measure derived from PPG and the state of microvessels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RESPeRATE (Paced Breathing), Quantum Warp10 (Red LED) and Omnilux new-U (Near Infrared LED)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Oct 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females, between 18 and 65 years of age.
- Willing to sign informed consent.
Who cannot join
- Currently smoking
- Any abnormal skin condition in the area of light irradiation.
- Pregnant having given birth less than 3 months ago, and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Having any illness that might affect the vasculature, such as diabetes (type I or II)
- Suffering from significant concurrent illness, such as cardiac disorders, , or pertinent neurological disorders.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating an Optical Index (Minimum Rise Time) as a Measure for the State of Microvessels
Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. The objective of the current study is to investigate a potential relationship between MRT (minimum rise time, in time units) a measure derived from PPG and the state of microvessels.
This study includes a 1-2 hour single session per subject during which PPG and other microvascular and systemic variables will be monitored in response to non-invasive interventions that are known to elicit microvascular responses.
Read the detailed description
Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. A major limitation of PPG is the lack of a quantitative method for calibrating this signal. A method that provides an absolute measure (in time units) called 'minimum rise time' (MRT) was published in 1985 by Dr. Benjamin Gavish, one of the study investigators. However, a possible relationship between MRT and the state of arterioles that determines the microvascular flow has never been investigated. Such relationship, if validated, could have clinical impact in noninvasive diagnosis of vascular diseases and monitoring microvascular response to treatments that affect at both clinic and home setting.
The objective of the current study is to investigate a potential relationship between variations of MRT (minimum rise time, in time units) and microcirculatory variables induced by interventions that are expected to have acute effect on the state of arterioles and the tissue oxygenation.
This study includes a single 1-2 hour session per subject, during which PPG and other microvascular and systemic variables will be monitored in healthy volunteers in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, and local temperature changes. The experimental sessions will be conducted at the Afeka College by the study investigators.
- Conditions
- Healthy
- Being tested
- RESPeRATE (Paced Breathing), Quantum Warp10 (Red LED), Omnilux new-U (Near Infrared LED), Heat/cold provocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPeRATE (Paced Breathing)Device
The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm.
Quantum Warp10 (Red LED)Device
Omnilux new-U (Near Infrared LED)Device
Heat/cold provocationOther
Immersion of one foot in a warm water bath ( 43-45 degrees C) for few seconds and then immersion of the same foot in cold water bath (5-7 degrees C) for 1 min.
| Study group | Role | What they receive |
|---|---|---|
| Red LED | Experimental | Light emitting diodes, 670 nm, 50 mW/cm2, Quantum Warp10 (Quantum Devices Inc, Barneveld, WI, USA); RESPeRATE; Heat/cold provocation Receives: Device: RESPeRATE (Paced Breathing); Device: Quantum Warp10 (Red LED); Other: Heat/cold provocation |
| Near Infrared LED | Active comparator | Light emitting diodes, 830 nm, 55 mW/cm2, Omnilux new-U (Photomedex, Horsham, PA, USA); RESPeRATE; Heat/cold provocation Receives: Device: RESPeRATE (Paced Breathing); Device: Omnilux new-U (Near Infrared LED); Other: Heat/cold provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRT as measured from finger Photoplethysmography in response to changes in breathing rate
Measured: Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)
MRT as measured from finger Photoplethysmography in response to light source
Measured: Change from immediately before exposure to light source to up to 10 minutes after exposure to light source
MRT as measured from finger Photoplethysmography in response to temperature changes
Measured: Change from immediately before exposure to temperature provocations to up to 2 minutes after exposure to warm water, and up to 2 minutes after exposure to cold water
Secondary outcomes (2)
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler
Measured: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes
Transcutaneous oxygen pressure (tcpO2 in mmHg)
Measured: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of Engineering
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Moshe Halak, MD, Principal investigator, Sheba Medical CenterZehava Blechman, PhD, Study director, Afeka, Tel-Aviv Academic College of Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527070
- Sponsor's protocol ID
- 2080-15-SMC
- Acronym
- MRT01
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gavish B. Plethysmographic characterization of vascular wall by a new parameter--minimum rise-time: age dependence in health. Microcirc Endothelium Lymphatics. 1986-1987;3(3-4):281-96.
PubMed 3431526
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Optical Index (Minimum Rise Time) as a Measure for the State of Microvessels
- ClinicalTrials.gov ID
- NCT02527070
- Acronym / sponsor ID
- MRT01 / 2080-15-SMC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of EngineeringUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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.
Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. The objective of the current study is to investigate a potential relationship between MRT (minimum rise time, in time units) a measure derived from PPG and the state of microvessels.
This study includes a 1-2 hour single session per subject during which PPG and other microvascular and systemic variables will be monitored in response to non-invasive interventions that are known to elicit microvascular responses.
Detailed description
Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. A major limitation of PPG is the lack of a quantitative method for calibrating this signal. A method that provides an absolute measure (in time units) called 'minimum rise time' (MRT) was published in 1985 by Dr. Benjamin Gavish, one of the study investigators. However, a possible relationship between MRT and the state of arterioles that determines the microvascular flow has never been investigated. Such relationship, if validated, could have clinical impact in noninvasive diagnosis of vascular diseases and monitoring microvascular response to treatments that affect at both clinic and home setting.
The objective of the current study is to investigate a potential relationship between variations of MRT (minimum rise time, in time units) and microcirculatory variables induced by interventions that are expected to have acute effect on the state of arterioles and the tissue oxygenation.
This study includes a single 1-2 hour session per subject, during which PPG and other microvascular and systemic variables will be monitored in healthy volunteers in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, and local temperature changes. The experimental sessions will be conducted at the Afeka College by the study investigators.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red LED | Experimental | Device: RESPeRATE (Paced Breathing), Device: Quantum Warp10 (Red LED), Other: Heat/cold provocationLight emitting diodes, 670 nm, 50 mW/cm2, Quantum Warp10 (Quantum Devices Inc, Barneveld, WI, USA); RESPeRATE; Heat/cold provocation |
| Near Infrared LED | Active comparator | Device: RESPeRATE (Paced Breathing), Device: Omnilux new-U (Near Infrared LED), Other: Heat/cold provocationLight emitting diodes, 830 nm, 55 mW/cm2, Omnilux new-U (Photomedex, Horsham, PA, USA); RESPeRATE; Heat/cold provocation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males and females, between 18 and 65 years of age.
- Willing to sign informed consent.
Key exclusion criteria (7 listed)
- Currently smoking
- Any abnormal skin condition in the area of light irradiation.
- Pregnant having given birth less than 3 months ago, and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Having any illness that might affect the vasculature, such as diabetes (type I or II)
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 |
|---|---|---|
| RESPeRATE (Paced Breathing)The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm. | Device | Near Infrared LED, Red LED |
| Quantum Warp10 (Red LED) | Device | Red LED |
| Omnilux new-U (Near Infrared LED) | Device | Near Infrared LED |
| Heat/cold provocationImmersion of one foot in a warm water bath ( 43-45 degrees C) for few seconds and then immersion of the same foot in cold water bath (5-7 degrees C) for 1 min. | Other | Near Infrared LED, Red LED |
Primary outcome
MRT as measured from finger Photoplethysmography in response to changes in breathing rate
Time frame: Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)
MRT as measured from finger Photoplethysmography in response to light source
Time frame: Change from immediately before exposure to light source to up to 10 minutes after exposure to light source
MRT as measured from finger Photoplethysmography in response to temperature changes
Time frame: Change from immediately before exposure to temperature provocations to up to 2 minutes after exposure to warm water, and up to 2 minutes after exposure to cold water
2 secondary outcomes
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler
Time frame: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes
Transcutaneous oxygen pressure (tcpO2 in mmHg)
Time frame: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes
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 17 Oct 2016.
- Results publication: PubMed 3431526Gavish B. Plethysmographic characterization of vascular wall by a new parameter--minimum rise-time: age dependence in health. Microcirc Endothelium Lymphatics. 1986-1987;3(3-4):281-96.
- Individual participant dataSharing planned: Undecided
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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.
Moshe Halak, MD principal investigator
Sheba Medical Center
Zehava Blechman, PhD study director
Afeka, Tel-Aviv Academic College of Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPeRATE (Paced Breathing), Quantum Warp10 (Red LED) and Omnilux new-U (Near Infrared LED) in people with Healthy, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
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 2 inclusion and 7 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 17 Oct 2016. 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 Israel. 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?
MRT as measured from finger Photoplethysmography in response to changes in breathing rate (time frame: Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)). 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 NCT02527070, which also lists 1 linked publication.
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 17 Oct 2016.