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Photobiomodulation, Heart Rate Variability, and Acute Stress

NCT07475858 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-02

No results posted yet for this study

Summary

Photobiomodulation (PBM) is a form of light therapy that uses red or near-infrared light to influence biological processes. In prior studies, PBM has been shown to improve various physiological functions, including tissue repair, inflammation, and cognitive performance. However, little is known about its impact on autonomic nervous system regulation. Thus, the goal of this study is to evaluate the effects of PBM on vagal activity, as measured by heart rate variability (HRV), in healthy adults undergoing experimental stress.

Conditions

  • Stress

Interventions

DEVICE

Vielight Vagus

In this study, PBM will be administered using a transcutaneous cervical plus intranasal PBM device (Vielight Vagus, Ontario, Canada). The transcutaneous component of the device is designed to be placed bilaterally over the lateral aspect of the neck and delivers an irradiance of 810nm at 50mW/cm2, while the intranasal component is designed to be inserted into the nasal cavity and provides an irradiance of 810nm at 25mW/cm2. The pulse frequency will be set to 100 Hz and 50% duty cycle.

OTHER

Sham Vielight Vagus

For sham intervention, the same PBM device will be placed on the participants in the same manner, but without emitting light to ensure blinding of the intervention.

Sponsors & Collaborators

  • Vielight Inc.

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Peter Wayne · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-05-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475858 on ClinicalTrials.gov