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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Capillary blood flow [Срок оценки: Up to 1 hour]

Вторичные конечные точки (1)

• Temperature distribution over hands measured by thermography [Срок оценки: Up to 1 hour]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Afeka, Tel-Aviv Academic College of Engineering — Tel Aviv

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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