Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography
NCT ID: NCT03357523
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-11-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Red LED
Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
Omnilux new-U (Red LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated
RESPeRATE
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
Heating bag
Applying a standard 10X13 \[cm\] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
Omnilux new-U (Near infrared LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated
RESPeRATE
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
Heating bag
Applying a standard 10X13 \[cm\] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
Interventions
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Omnilux new-U (Red LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated
Omnilux new-U (Near infrared LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated
RESPeRATE
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
Heating bag
Applying a standard 10X13 \[cm\] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
Eligibility Criteria
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Inclusion Criteria
2. Willing to sign informed consent
Exclusion Criteria
2. Any abnormal skin condition in the area of light irradiation.
3. Pregnant having given birth less than 3 months ago, and/or breastfeeding.
4. 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.
5. Having any illness that might affect the vasculature, such as diabetes (type I or II)
6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
23 Years
45 Years
ALL
Yes
Sponsors
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Hebrew University of Jerusalem
OTHER
Afeka, The Tel-Aviv Academic College of Engineering
OTHER
Responsible Party
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Principal Investigators
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Zehava Blechman, PhD
Role: PRINCIPAL_INVESTIGATOR
Afeka Tel Aviv Academic College of Engineering
Locations
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Afeka, Tel-Aviv Academic College of Engineering
Tel Aviv, , Israel
Countries
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References
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Gavish L, Hoffer O, Rabin N, Halak M, Shkilevich S, Shayovitz Y, Weizman G, Haim O, Gavish B, Gertz SD, Ovadia-Blechman Z. Microcirculatory Response to Photobiomodulation-Why Some Respond and Others Do Not: A Randomized Controlled Study. Lasers Surg Med. 2020 Nov;52(9):863-872. doi: 10.1002/lsm.23225. Epub 2020 Feb 17.
Other Identifiers
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05.04.2017-1-AFK
Identifier Type: -
Identifier Source: org_study_id