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临床试验/NCT07475858
NCT07475858尚未招募不适用

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

Brigham and Women's Hospital0 个研究点目标入组 40 人开始时间: 2026年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Change in HRV, as measured by RMSSD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults, aged 18-64 years
  • Ability to read and understand English
  • Willing to comply with the study procedures and attend all scheduled sessions

排除标准

  • 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

研究组 & 干预措施

Real PBM before stress induction

Active Comparator

After a 5-minute baseline measurement, participants will receive 20 minutes of real PBM. They will then complete the 15-minute MAST protocol (stress induction) and be monitored for additional 10 minutes to assess recovery from stress.

干预措施: Vielight Vagus (Device)

Sham PBM before stress induction

Sham Comparator

After a 5-minute baseline measurement, participants will receive 20 minutes of sham PBM. They will then complete the 15-minute MAST protocol (stress induction) and be monitored for additional 10 minutes to assess recovery from stress.

干预措施: Sham Vielight Vagus (Other)

Real PBM after stress induction

Active Comparator

After a 5-minute baseline measurement, participants will undergo the 15-minute MAST protocol (stress induction), followed by 20 minutes of real PBM and 10 minutes of post-intervention period.

干预措施: Vielight Vagus (Device)

Sham PBM after stress induction

Sham Comparator

After a 5-minute baseline measurement, participants will undergo the 15-minute MAST protocol (stress induction), followed by 20 minutes of sham PBM and 10 minutes of post-intervention period.

干预措施: Sham Vielight Vagus (Other)

结局指标

主要结局

Change in HRV, as measured by RMSSD

时间窗: 50 minutes

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.

次要结局

  • Change in electrodermal activity (EDA)(50 minutes)
  • Change in blood pressure (BP)(50 minutes)
  • Change in state anxiety(50 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter M. Wayne, Ph.D.

Principal Investigator

Brigham and Women's Hospital

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