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Enrolling by invitation NCT07338695

The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature

No phase Interventional Microcirculation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photobiomodulation - Blue Wavelength, Photobiomodulation - Near Infrared.
Who it may be relevant to
Registry conditions: Microcirculation. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Hemodynamic Changes in Peripheral Microcirculation in Response to Photobiomodulation Using Non-Invasive Optical and Thermal Technologies

Overview

The objective of this study is to assess peripheral microcirculatory hemodynamic responses to photobiomodulation in participants with normal circulation and with functional peripheral vasoconstriction, using noninvasive thermography, photoplethysmography, and laser Doppler flowmetry.

Detailed description

This is a within-subject experimental study in which each participant completes two study sessions. Microvascular and systemic variables are continuously monitored in response to photobiomodulation delivered at either a blue or near-infrared wavelength, with each wavelength applied in a separate session.

Each session includes a baseline period with controlled breathing, followed by photobiomodulation and a 20-minute post-intervention follow-up period. Peripheral microcirculatory responses are assessed using noninvasive thermography, photoplethysmography, and laser Doppler flowmetry.

Interventions

  • Device Photobiomodulation - Blue Wavelength
    Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.
  • Device Photobiomodulation - Near Infrared
    Photobiomodulation delivered at a near-infrared wavelength (780-1100 nm) to the hands during a single study session as part of a randomized crossover design.

Primary outcome measures

  • Capillary blood flow [Time frame: Up to 1 hour]
Secondary outcome measures (1)
  • Temperature distribution over hands measured by thermography [Time frame: Up to 1 hour]

Eligibility criteria

Inclusion criteria

  • Healthy males and females, between 20 and 75 years of age.
  • Willing to sign informed consent.
  • Willing to participate in two separate sessions, one for each wavelength.
  • Able to avoid caffeine and alcohol for at least 3 hours before each session.
  • Able to sit comfortably with both hands at heart level for the full measurement duration.

Exclusion criteria

  • Currently smoking
  • Any abnormal skin condition in the area of light irradiation.
  • Pregnant, having given birth less than 3 months ago, and/or breastfeeding.
  • History of photosensitive conditions or use of photosensitizing medications
  • Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
  • As per the Investigator's discretion, any physical or mental condition that might make it unsafe for the subject to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Afeka, Tel-Aviv Academic College of Engineering — Tel Aviv

Publications

  • 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. PMID 32064652
  • Ovadia-Blechman Z, Hauptman Y, Rabin N, Wiezman G, Hoffer O, Gertz SD, Gavish B, Gavish L. Morphological features of the photoplethysmographic signal: a new approach to characterize the microcirculatory response to photobiomodulation. Front Physiol. 2023 Sep 25;14:1175470. doi: 10.3389/fphys.2023.1175470. eCollection 2023. PMID 37817983

Identifiers

NCT: NCT07338695 · 09-12-2024-AFK · PBM&MBF01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗