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

NCT ID: NCT07338695

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Microcirculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a within-subject crossover study in which participants receive photobiomodulation at blue and near-infrared wavelengths in separate sessions, with the order of exposure assigned in a crossover manner. Participants may present with functional peripheral vasoconstriction or normal peripheral temperature at baseline; these baseline characteristics will be used for subgroup analyses and do not define separate study arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blue → Near-Infrared PBM

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

Group Type EXPERIMENTAL

Photobiomodulation - Blue Wavelength

Intervention Type DEVICE

Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.

Photobiomodulation - Near Infrared

Intervention Type DEVICE

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.

Near-Infrared → Blue PBM

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

Group Type EXPERIMENTAL

Photobiomodulation - Blue Wavelength

Intervention Type DEVICE

Photobiomodulation delivered at a blue wavelength (400-500 nm) to the hands during a single study session as part of a randomized crossover design.

Photobiomodulation - Near Infrared

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Afeka, The Tel-Aviv Academic College of Engineering

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, , Israel

Site Status

Countries

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Israel

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.

Reference Type BACKGROUND
PMID: 32064652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37817983 (View on PubMed)

Other Identifiers

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09-12-2024-AFK

Identifier Type: -

Identifier Source: org_study_id

PBM&MBF01

Identifier Type: OTHER

Identifier Source: secondary_id

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