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

NCT07190417 | Completed

• 1 other identifier: YM109166F
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insomnia; Anxiety; Acupuncture; Acupoint Stimulation; Low-Level Laser Therapy (LLLT); Heart Rate Variability (HRV); Meridian Energy; Traditional Chinese Medicine (TCM)

Outcome Measures

Primary Outcomes (1)

• Heart rate variability of Healthy Participant during Low-Energy LED Therapy

  Heart rate variability is measured by using Wegene Electrocardiogram Recorder (Medical Device License No. 004896 of the Ministry of Health): Developed by National Yang-Ming University and in cooperation with Wegene Technology, this handheld heart rate measurement system allows users to measure heart rate variability parameters in a relaxed manner and reflect the main parameters on the dashboard in real time. The primary unit of measure for heart rate variability (HRV). HRV reflects the variation in time between consecutive heartbeats(bpm), and this variation is typically very small, measured in milliseconds. HRV parameters includes Total Power, TP \[ln(ms²)\], Standard deviation of Normal to Normal R Wave, SDNN(ms²), High Frequency, HF \[ln(ms²)\], Low Frequency, LF \[ln(ms²)\], Very Low Frequency, VLF \[ln(ms²)\], percentage of HF(%), percentage of LF(%), LF/HF ratio.

  Measure three times: before, during, and after, each lasting 5 minutes

Secondary Outcomes (1)

• Meridian Energy Measurement of Healthy Participant during Low-Energy LED Therapy.

  Measure two times: before and after, each lasting for 6 minutes

Other Outcomes (1)

• To investigate how light from LEDs and lasers penetrates different skin types.

  The experiment takes about 15 seconds for measuring and recording each light source, total time duration needed for each participants is 30 minutes.

Study Arms (3)

Preliminary experiment on low-energy laser acupuncture for insomnia (healthy subjects, single-blind)

SHAM COMPARATOR

Objective: To evaluate the effectiveness of low-energy LED therapy on acupoints in treating insomnia, considering Fitzpatrick skin type variations. Methods: 90 participants (Fitzpatrick types I-VI) from National Yang-Ming Chiao Tung University will be recruited. Participants will receive either low-energy LED or sham therapy for 25 minutes, twice, in a controlled environment. Heart rate variability, meridian energy, and light penetration will be measured before, during, and after the intervention. Note: This version removes unnecessary details about the time of day, temperature, and eye safety. It focuses on the core elements of the study: the intervention, the participants, the measurements, and the overall objective.

Other: LEDs and laser light

Preliminary experiment on the use of low-energy LED for acupuncture for insomnia (Double-blind)

SHAM COMPARATOR

This experiment is similar to Experiment A, but the sham light intervention will use a sham device. The design will be double-blind. Experiment personnel (B) will randomly assign participants to wear either the low-energy LED device or the sham device. Experiment personnel (A) will assist participants in wearing the devices and measuring signals. Prior to the completion of the experiment, personnel (A) will not be aware of which device (LED or sham) is actually emitting light (the near-infrared light from the LED is difficult to see even with the naked eye after scattering). The low-energy LED device and the sham device will have identical indicator lights, operating cycles, and sound indicators.

Other: LEDs and laser light

To investigate how light from LEDs and lasers penetrates different skin types.

EXPERIMENTAL

This study will investigate how light from LEDs and lasers penetrates different skin types. Participants: 90 participants (Fitzpatrick Skin Types I-VI) will be recruited from National Yang-Ming Chiao Tung University. 60 participants will be from previous experiments, and 30 from international students. Procedure: Categorize participants into six groups based on Fitzpatrick skin type. Measure initial light power of the LED and laser sources. Mark a target point on the participant's earlobe or ear cartilage. Measure the thickness of the earlobe/cartilage. Measure light power after penetrating through the earlobe/cartilage. Calculate light power reduction (attenuation) for LED and laser interventions. Analyze light transmission percentages across Fitzpatrick skin types to assess LED light penetration suitability. Goal: To determine if light penetration is affected by skin color.

Other: LEDs and laser light

Interventions

LEDs and laser light OTHER

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.

Also known as: LED, Laser therapy, laser acupuncture

Preliminary experiment on low-energy laser acupuncture for insomnia (healthy subjects, single-blind); Preliminary experiment on the use of low-energy LED for acupuncture for insomnia (Double-blind); To investigate how light from LEDs and lasers penetrates different skin types.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No use of sleeping pills within the past 3 months.
• Pittsburgh Sleep Quality Index (PSQI) \< 5 points.
• Body Mass Index (BMI): 18.5 \< BMI \< 30.
• Blood pressure: within normal range (\<140 mmHg/90 mmHg).
• Individuals with regular wake-sleep times: bedtime between 22:00 and 02:00.

You may not qualify if:

• Individuals with insomnia and other sleep disorders.
• Exclude those currently taking medications.
• Individuals with cardiovascular diseases, cancer, psychiatric disorders, kidney diseases, diabetes, chronic illnesses, and physical discomfort.
• Exclude individuals with addictions to smoking, alcohol, caffeine, and drugs.
• Individuals with light sensitive skin.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Institute of Brain Science

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Interventions

Lasers; Laser Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: September 24, 2025
• Study Start: March 5, 2021
• Primary Completion: May 4, 2021
• Study Completion: June 20, 2025
• Last Updated: September 24, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)