Photobiomodulation, Heart Rate Variability, and Acute Stress
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: Vielight Vagus, Sham Vielight Vagus.
- Who it may be relevant to
- Registry conditions: Stress. Basic parameters: 18 years — 64 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Photobiomodulation on Heart Rate Variability in Healthy Adults Subjected to the Maastricht Acute Stress Test (MAST): A Sham-controlled, Within-subject Study
Overview
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.
Detailed description
Photobiomodulation (PBM) is a non-invasive therapeutic technique that uses low-level light, typically in the red or near-infrared spectrum, to stimulate biological tissues. This approach has been increasingly studied for its beneficial effects on wound healing, mood, and sleep quality. Recent research has also highlighted PBM's potential in enhancing brain function, neuroplasticity, and cognitive performance. For example, prior studies have demonstrated that transcranial PBM (i.e., PBM delivered to the head) can help modulate neuronal activity, improve cerebral blood flow, and promote neuroprotective effects for traumatic brain injury and stroke. Given these findings, PBM may also have potential for influencing autonomic function and stress physiology. However, to date, little is known about the effects of PBM on the autonomic nervous system, particularly its influence on vagal activity and heart rate variability (HRV).
This study aims to fill this gap by investigating the effects of transcutaneous cervical plus intranasal PBM on HRV in healthy individuals subjected to experimental stress. Specifically, the Maastricht Acute Stress Test (MAST) will be used, which is a validated stress protocol that has been shown to strongly and reliably induce acute autonomic stress responses. A within-subject design will be employed with four repeated visits per participant to examine the effects of both PBM and sham intervention applied before and after stress induction on vagal activity, as measured by HRV. As the first study to examine PBM's impact on HRV, this research will provide valuable insights into the potential of PBM as a novel, non-invasive approach to modulating autonomic regulation, particularly in the context of 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.
Primary outcome measures
- Change in HRV, as measured by RMSSD [Time frame: 50 minutes]
Secondary outcome measures (3)
- Change in electrodermal activity (EDA) [Time frame: 50 minutes]
- Change in blood pressure (BP) [Time frame: 50 minutes]
- Change in state anxiety [Time frame: 50 minutes]
Eligibility criteria
Inclusion criteria
- Healthy adults, aged 18-64 years
- Ability to read and understand English
- Willing to comply with the study procedures and attend all scheduled sessions
Exclusion criteria
- Taking medications that could significantly influence autonomic function
- Presence or history of any serious cardiovascular, inflammatory, and pain conditions as well as neurological disorders or other conditions that affect the central nervous system
- Pregnant
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
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07475858 · 2026P000281