Effect of Low Level Light Irradiation on Insomniacs' Meridians During the First Sleep Cycle.

NCT05426226 | Unknown

• 1 other identifier: IRB 2022-02-027B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction In the past, it was found that stimulating the meridians and acupoints with low-level light often had a good effect. However, for safety reasons, most instruments such as laser acupuncture devices still need to be used by medical personnel, and it is difficult to apply to insomnia patients at bed-time or the first sleep cycle, these two periods have a considerable impact on sleep quality. Therefore, the purpose of this study is to provide a safer wearable light-therapy device for Insomnia patients, so that it can be used in home sleep situations, and the improvement of subjects' sleep qualtity and meridian energy will be evaluated by PSG, HRV parameters, sleep questionnaires, and Ryodoraku value (reflects the meridian electric resistance). Methods Aim1: To evaluate whether the subjects are more relaxed by observing the changes in heart rate and meridian energy of healthy subjects after low-level light irradiating to Shenmen, Daling, Neiguan (acupoints for insomnia). We also consider the difference of light source and the skin color in experiment design. Aim2: To assess whether the insomnia patients' sleep quality has improved after applying the wearable light therapy device to subjects' bed-time (include the first sleep cycle). We use PSG, sleep questionnaires, stroop test for evaluation.

Conditions

Insomnia

Keywords

Heart rate variability; meridian; insomnia

Outcome Measures

Primary Outcomes (2)

• Differences in sleep EEG before and after the laser irradiation compared to the sham group

  According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality

  Change from Baseline sleep EEG at 67 days

• Differences in Heart rate variability before and after the laser irradiation compared to the sham group

  HRV is measured by the variations in the R-R interval between the successive peaks of the QRS complex in the ECG wave. Based on fast Fourier transform, time-domain (R-R interval) transfer to frequency domain resulting total power (TP, 0.04-0.15), low frequency (LF, 0.06-0.6Hz), high frequency (HF, 0.6-2.4Hz), normalized LF (LF%) and LF/HF ratio are obtained. LF% and HF represent an index of sympathetic activity and parasympathetic activity respectively. LF/HF is indicative of the sympathetic to parasympathetic autonomic balance.

  Change from heart rate variability parameters at 67 days

Secondary Outcomes (8)

• Differences in the Epworth Sleepiness Scale (ESS) before and after the laser irradiation compared to the sham group.

  Change from Baseline ESS at 67 days

• Differences in Visual Analogue Scale (VAS) before and after the laser irradiation compared to the sham group.

  Change from Baseline VAS at 67 days

• Differences in scores of stroop test before and after the laser irradiation compared to the sham group.

  Change from Baseline score of stroop at 67 days

• Differences in the Insomnia Severity Index (ISI) before and after the laser irradiation compared to the sham group.

  Change from Baseline ISI at 67 days

• Differences in the Pittsburgh sleep quality index before and after the laser irradiation compared to the sham group.

  Change from Baseline PSQI at 67 days

Study Arms (2)

laser group

ACTIVE COMPARATOR

Laser group use specific wavelength to light the sleep acupoints during. If the laser group take light acupuncture in the first month, and then become the sham group in the next month, vice versa.

Device: laser acupuncture

sham group

SHAM COMPARATOR

sham group use the same divce and acupointsas the laser group, but the light is just a regular light. If the laser group take light acupuncture in the first month, and then become the sham group in the next month, vice versa.

Device: sham device

Interventions

laser acupuncture DEVICE

using laser acupuncture device on sleep acupoints during sleep

laser group

sham device DEVICE

using sham device on sleep acupoints during sleep

sham group

Eligibility Criteria

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

You may qualify if:

• aged 20 to 65 years
• No sleep pills for 3 months
• Body Mass Index (BMI) : 18.5-30
• Blood pressure: within normal range (140 mmHg/90 mmHg)
• People with regular wake-up time
• The bedtime is between 22:00 and 2:00.

You may not qualify if:

• People with sleep disorders other than insomnia
• those currently taking drugs;
• with cardiovascular disease, cancer, psychiatric disease, kidney disease, diabetes, chronic disease and physical discomfort
• Exclude tobacco, alcohol, caffeine, and drug addicts
• Exclude from fitzpatrick skin type classification - V and VI (skin is black and dark brown)
• People whose skin is allergic to light (light sensitivity, solar dermatitis).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuan-Pu Tseng, MD

  Center for Traditional Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Pu Tseng, MD

CONTACT

886-2-28757453; m061j3@gmail.com

Yu-Ting Ho

CONTACT

886-968006520; mascottofu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants allocation by third party
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Traditional Medicine,Attending Doctor, Principal Investigator,

Model Details: The subjects were randomly assigned to group A and group B, the group A will take light acupuncture in the first month, and sham in the next month; Group B is opposite.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 21, 2022
• Study Start: August 10, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)