Evaluation of Physiological Effects Induced by Low Level Light Irradiation on the Acupoints of the Hand

Summary

The goal of this clinical trial is to determine if low-level laser therapy (LLLT) and LED-based low-level light therapy (LLLT) are effective in inducing relaxation and improving sleep quality and anxiety levels in individuals with insomnia. It aims to evaluate the potential of both light sources to elicit comparable physiological changes in relation to acupoint stimulation.

The main questions this trial aims to answer are:

Does exposure to low-level laser or LED light therapy on specific acupoints associated with insomnia result in similar changes in heart rate variability and meridian energy? How does skin pigmentation affect the penetration of different wavelength light sources used in LLLT? Primary hypothesis 1: Low-level LED light therapy is comparable to laser therapy in terms of effectiveness.

Primary hypothesis 2: With proper design, both treatments will elicit similar changes in meridian energy and heart rate variability.

Researchers will compare the effects of low-level laser and LED light therapy on 60 participants, divided into two groups: 30 healthy participants receiving either low-level laser/sham laser or low-level LED/sham LED light exposure and 30 participants with brown to black skin tones receiving different LED and laser specifications.

Participants will:

Undergo either low-level laser/sham laser or low-level LED/sham LED light exposure on specific acupoints.

Have their heart rate variability and meridian energy levels measured before and after the intervention.

Have their skin pigmentation measured to assess light penetration with various wavelengths.

This study seeks to establish a stronger link between acupoint stimulation, light therapy, and sleep neuroscience, potentially offering an alternative therapeutic approach for insomnia that complements existing pharmacological interventions.

Conditions

• Insomnia
• Anxiety
• Acupuncture
• Low-level Laser Therapy

Interventions

OTHER

LEDs and laser light

Experiment 1：Measure the heart rate parameters before, during, and after laser acupuncture or LED light therapy within a 25-minute experimental period, and observe the changes in the subjects' meridian energy before and after the treatment, followed by analysis. Acupoint selections mainly include Daling, Neiguan, and Shenmen. Experiment 2：randomly assigns subjects to wear either a low-energy LED device or a sham device. The indicators, duty cycles, and sounds of the low-energy LED device and the sham device are all the same. Experiment 3：Place light sources of different wavelengths on the earlobes or auricles of subjects with different skin tones. By observing the changes in light power before and after, the investigators can infer the effects of skin tone on light attenuation and transmission of light sources with different wavelengths.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-05

Primary Completion

2021-05-04

Completion

2025-06-20

Countries

• Taiwan

Study Locations