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Photobiomodulation, Heart Rate Variability, and Acute Stress

ConditionStress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults, aged 18-64 years

Ability to read and understand English

Willing to comply with the study procedures and attend all scheduled sessions

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Vielight Vagus

    Device

    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.

  • Sham Vielight Vagus

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Real PBM before stress inductionActive comparator 1 intervention
Group B: Sham PBM before stress inductionSham comparator 1 intervention
Group C: Real PBM after stress inductionActive comparator 1 intervention
Group D: Sham PBM after stress inductionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HRV, as measured by RMSSD

Root mean square of successive differences (RMSSD) is a commonly used time-domain measure of HRV. It is commonly used to assess autonomic regulation, with higher RMSSD indicating greater parasympathetic activity and vagal tone. In this study, RMSSD will be calculated for every 5-minute segments of HRV data from baseline to post-phase. The area under the curve (AUC) will be computed to assess changes in RMSSD values with respect to baseline. This approach will allow for a comprehensive evaluation of changes in parasympathetic activity, in both magnitude and variability over time under different experimental conditions. Paired t-tests will then be used to compare AUCs between PBM and sham interventions, separately for before and after stress induction.

Time frame
50 minutes

Secondary outcomes

1

Change in electrodermal activity (EDA)

Similar to ECG/HRV, EDA data will be measured continuously from baseline to post-phase for 50 minutes, to provide a more comprehensive assessment of the autonomic responses.

Time frame
50 minutes
2

Change in blood pressure (BP)

BP will be assessed every 5 minutes during each visit's study procedures.

Time frame
50 minutes
3

Change in state anxiety

Participants will be asked to complete the state anxiety subscale of the State-Trait Anxiety Inventory (STAI) two times for each visit, initially before baseline and then during the post-phase period.

Time frame
50 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Vielight Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: