InsomniaAcupunctureNCT07190417
Evaluation of Physiological Effects Induced by Low Level Light Irradiation on the Acupoints of the Hand
A study testing LEDs and laser light in people with Insomnia and Anxiety, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Anxiety, Acupuncture
- What is being tested?
- LEDs and laser light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2021to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed description
Research Background： In recent years, acupuncture has emerged as a promising therapeutic approach for improving sleep quality in menopausal women, particularly in addressing the challenging aspect of deepening sleep. This has led to an increased focus on acupunctural treatments, including acupoint stimulation, as a potential solution for insomnia. However, with increasingly stringent medical regulations, even non-invasive low-level laser therapy, despite its significantly safer profile compared to traditional acupuncture needles, faces substantial regulatory hurdles.
Meanwhile, novel LED technology presents a compelling alternative to lasers. Compared to lasers of equivalent power, LEDs boast lower costs, energy consumption, and operating temperatures without compromising therapeutic efficacy. This makes LED-based low-level light therapy (LLLT) a highly promising approach, especially for applications where diverse medical needs are present, such as in organizations like NASA.
This study is a preliminary investigation into the application of acupoint light therapy within the realm of Traditional Chinese Medicine (TCM) for managing insomnia and anxiety. The objective is to evaluate the potential of both low-level laser therapy and low-level LED light therapy, under similar power and wavelength conditions, to induce comparable physiological changes and consequently improve sleep quality and alleviate anxiety.
Specifically, this research will examine whether exposure to either light source results in similar relaxation effects by analyzing relevant physiological indicators like heart rate variability parameters and conductive meridian (Jingluo) parameters - a measure of electrical resistance along meridians. Furthermore, this study will address the understudied influence of skin pigmentation on LLLT by conducting optical experiments to determine the penetration depth of light sources with varying wavelengths through different skin types. This will contribute to a more comprehensive understanding of the application of LLLT in acupoint stimulation.
Research Objectives:
Investigate the effects of low-level laser and LED light therapy on acupoints associated with insomnia in the hands, using heart rate variability parameters and conductive meridian resistance (Jingluo) measurements as assessment tools.
Clarify the influence of skin pigmentation on the propagation of low-level laser and LED light by using a light power meter to quantify the difference in light transmission through darker and lighter skin types for various wavelengths.
Hypothesis:
Low-level LED light therapy is comparable to laser therapy in terms of its effectiveness. With proper design, both treatments will elicit similar changes in meridian energy and heart rate variability.
Data and Methods:
A total of 90 participants will be recruited for this study, divided into two groups:
Group 1: Consists of 30 healthy participants who will undergo either low-level laser/sham laser or low-level LED/sham LED light exposure. Changes in meridian energy and heart rate variability will be assessed after the intervention. Participants in this group will also be required to undergo pre- and post-light exposure measurements using different LED and laser specifications.
Group 2: Includes 30 participants with skin tones ranging from brown to black, categorized using the Fitzpatrick skin type scale. They will also undergo pre- and post-light exposure measurements using different LED and laser specifications.
Expected Results:
This study anticipates observing changes in meridian resistance and heart rate variability parameters following the application of low-level light stimulation to acupoints. By evaluating the penetration of light sources of various wavelengths through different human tissues, the study aims to establish a stronger link between LLLT and physiological indicators related to relaxation.
Significance:
This research aims to create a stronger connection between the practices of TCM acupoint stimulation, light therapy, and sleep neuroscience. The findings have the potential to provide an alternative therapeutic option for individuals suffering from insomnia, complementing existing pharmacologic interventions.
- Conditions
- Insomnia, Anxiety, Acupuncture, Low-level Laser Therapy
- Being tested
- LEDs and laser light
- Keywords
- Insomnia, Anxiety, Acupuncture, Acupoint Stimulation, Low-Level Laser Therapy (LLLT), Heart Rate Variability (HRV), Meridian Energy, Traditional Chinese Medicine (TCM)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEDs and laser lightOther
Also called LED, Laser therapy, laser acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: LEDs and laser light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
A spring-loaded probe, is moistened with 5% saline and, after sterilization, applied sequentially to the 24 Yuan acupoints. After 2-3 seconds of 12 g/cm2 pressure for each point, the device is automatically interrupted, and the average value is recorded on a computerized system. In Meridian Energy Analysis (MEA), the primary unit of measure is electrical conductance, typically expressed in microamperes (μA). This measurement reflects the flow of electrical current through the meridian pathways, which can measure the vital energy (Qi) in traditional Chinese medicine. The MEA device used in the investigation is the Meridian Energy Analysis Device (MEAD). It uses a small electrical current (200 μA) to measure the Qi of the 24 pathways and their associated energy levels.
Measured: Measure two times: before and after, each lasting for 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start5 Mar 2021
- Primary completion4 May 2021
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190417
- Sponsor's protocol ID
- YM109166F
- Acronym
- Acupuncture
- Status last verified
- May 2024
- First submitted
- 4 Mar 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physiological Effects Induced by Low Level Light Irradiation on the Acupoints of the Hand
- ClinicalTrials.gov ID
- NCT07190417
- Acronym / sponsor ID
- Acupuncture / YM109166F
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Background： In recent years, acupuncture has emerged as a promising therapeutic approach for improving sleep quality in menopausal women, particularly in addressing the challenging aspect of deepening sleep. This has led to an increased focus on acupunctural treatments, including acupoint stimulation, as a potential solution for insomnia. However, with increasingly stringent medical regulations, even non-invasive low-level laser therapy, despite its significantly safer profile compared to traditional acupuncture needles, faces substantial regulatory hurdles.
Meanwhile, novel LED technology presents a compelling alternative to lasers. Compared to lasers of equivalent power, LEDs boast lower costs, energy consumption, and operating temperatures without compromising therapeutic efficacy. This makes LED-based low-level light therapy (LLLT) a highly promising approach, especially for applications where diverse medical needs are present, such as in organizations like NASA.
This study is a preliminary investigation into the application of acupoint light therapy within the realm of Traditional Chinese Medicine (TCM) for managing insomnia and anxiety. The objective is to evaluate the potential of both low-level laser therapy and low-level LED light therapy, under similar power and wavelength conditions, to induce comparable physiological changes and consequently improve sleep quality and alleviate anxiety.
Specifically, this research will examine whether exposure to either light source results in similar relaxation effects by analyzing relevant physiological indicators like heart rate variability parameters and conductive meridian (Jingluo) parameters - a measure of electrical resistance along meridians. Furthermore, this study will address the understudied influence of skin pigmentation on LLLT by conducting optical experiments to determine the penetration depth of light sources with varying wavelengths through different skin types. This will contribute to a more comprehensive understanding of the application of LLLT in acupoint stimulation.
Research Objectives:
Investigate the effects of low-level laser and LED light therapy on acupoints associated with insomnia in the hands, using heart rate variability parameters and conductive meridian resistance (Jingluo) measurements as assessment tools.
Clarify the influence of skin pigmentation on the propagation of low-level laser and LED light by using a light power meter to quantify the difference in light transmission through darker and lighter skin types for various wavelengths.
Hypothesis:
Low-level LED light therapy is comparable to laser therapy in terms of its effectiveness. With proper design, both treatments will elicit similar changes in meridian energy and heart rate variability.
Data and Methods:
A total of 90 participants will be recruited for this study, divided into two groups:
Group 1: Consists of 30 healthy participants who will undergo either low-level laser/sham laser or low-level LED/sham LED light exposure. Changes in meridian energy and heart rate variability will be assessed after the intervention. Participants in this group will also be required to undergo pre- and post-light exposure measurements using different LED and laser specifications.
Group 2: Includes 30 participants with skin tones ranging from brown to black, categorized using the Fitzpatrick skin type scale. They will also undergo pre- and post-light exposure measurements using different LED and laser specifications.
Expected Results:
This study anticipates observing changes in meridian resistance and heart rate variability parameters following the application of low-level light stimulation to acupoints. By evaluating the penetration of light sources of various wavelengths through different human tissues, the study aims to establish a stronger link between LLLT and physiological indicators related to relaxation.
Significance:
This research aims to create a stronger connection between the practices of TCM acupoint stimulation, light therapy, and sleep neuroscience. The findings have the potential to provide an alternative therapeutic option for individuals suffering from insomnia, complementing existing pharmacologic interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preliminary experiment on low-energy laser acupuncture for insomnia (healthy subjects, single-blind) | Sham comparator | Other: LEDs and laser lightObjective: 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. |
| Preliminary experiment on the use of low-energy LED for acupuncture for insomnia (Double-blind) | Sham comparator | Other: LEDs and laser lightThis 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. |
| To investigate how light from LEDs and lasers penetrates different skin types. | Experimental | Other: LEDs and laser lightThis 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEDs and laser lightAlso: LED, Laser therapy, laser acupunctureExperiment 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. | Other | 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. |
Primary outcome
Heart rate variability of Healthy Participant during Low-Energy LED Therapy
Time frame: Measure three times: before, during, and after, each lasting 5 minutes
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.
1 secondary outcome
Meridian Energy Measurement of Healthy Participant during Low-Energy LED Therapy.
Time frame: Measure two times: before and after, each lasting for 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEDs and laser light in people with Insomnia and Anxiety, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability of Healthy Participant during Low-Energy LED Therapy (time frame: Measure three times: before, during, and after, each lasting 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.