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

NCT05426226 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-01

No results posted yet for this study

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

Interventions

DEVICE

laser acupuncture

using laser acupuncture device on sleep acupoints during sleep

DEVICE

sham device

using sham device on sleep acupoints during sleep

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Yuan-Pu Tseng, MD · Center for Traditional Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426226 on ClinicalTrials.gov