The Effect of Photobiomodulation on Microvascular Blood Flow: The Role of Wavelength and Skin Temperature (PBM&MBF01)

Afeka, The Tel-Aviv Academic College of Engineering

Status: Invitation-only

Conditions: Microcirculation

Treatments: Device: Photobiomodulation - Blue Wavelength; Device: Photobiomodulation - Near Infrared

Study type: Interventional

Funder types: Other

Identifiers

NCT07338695

PBM&MBF01 (Other Identifier)

09-12-2024-AFK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Currently smoking
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. History of photosensitive conditions or use of photosensitizing medications
5. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
6. As per the Investigator's discretion, any physical or mental condition that might make it unsafe for the subject to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Blue → Near-Infrared PBM

Experimental group

Description:

Participants receive photobiomodulation at a blue wavelength in the first session and at a near-infrared wavelength in the second session.

Treatment:

Device: Photobiomodulation - Near Infrared

Device: Photobiomodulation - Blue Wavelength

Near-Infrared → Blue PBM

Experimental group

Description:

Participants receive photobiomodulation at a near-infrared wavelength in the first session and at a blue wavelength in the second session.

Treatment:

Device: Photobiomodulation - Near Infrared

Device: Photobiomodulation - Blue Wavelength