Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05426226
Status:
UNKNOWN
Last Update Posted:
2022-08-01
First Post:
2022-06-16
Brief Title:
Effect of Low Level Light Irradiation on Insomniacs Meridians During the First Sleep Cycle
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Effect of Low Level Light Irradiation on Insomniacs Meridians During the First Sleep Cycle
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Hypotheses and Aims
In the past there are no studies on using light acupuncture during the first sleep cycle or bed-time So we have the following hypotheses First irradiating low level light on the sleep acupoints during these periods will strengthen the activity of the parasympathetic during these periods Second the activity of the parasympathetic will improve the quality of sleep in the first sleep cycle because the parasympathetic activity of sleep onsetSO is an indicator of sleep quality Third the improvement of sleep quality in the first sleep cycle will affect the quality of total sleep and daytime cognitive functions I divide the research hypotheses for details into three categories
Part 1 To observe the relationship between light stimulation of traditional Chinese medicine TCM sleep-aiding acupoints
Hypothesis 1-1 After the laser stimulates the sleep-aiding acupoints the energy of the meridian that is too high will decrease and the energy of the meridian that is too low will increase
Hypothesis 1-2 After laser acupuncture the qi of the meridians will not be consumed too quickly like acupuncture so the needle retention is safe
Hypothesis 1-3 The efficacy of LED stimulation of acupoints should be similar to that of laser acupuncture
Part 2 Assumptions Related to Optical Design
Hypothesis 2-1 The most suitable light specifications for dark-skinned people are different from light-skinned people
Hypothesis 2-2 Some new optical components have good performance in light transmission Hypothesis 2-3 The newly designed light penetration experiment can obtain optical parameters more accurately and quickly
Part 3 Heart Rate Variability and Sleep Improvement
Hypothesis 3-1 We could improve parameters of heart rate variability by using the wearable light therapy device
Hypothesis 3-2 Optimizing HRV parameters before going to bed can improve the quality of the first sleep cycle
Hypothesis 3-3 After using a wearable light therapy device to improve the first sleep cycle it can also enhance the whole night sleep quality
Hypothesis 3-4 Improved sleep quality from using wearable light therapy device can lead to the improvements in daily cognitive function
Significance If this study is successfully proved to improve the sleep quality of insomnia patients it will give insomnia patients a treatment option other than sleep pills make light therapy be widely applied to the home environment and make researchers pay more attention to the possibility of using TCM procedure in the first sleep cycle
Research Materials and Equipment Research Methods
STAGE 1
Participant
Experiment A
A preliminary experiment of laser acupuncture on sleep acupoints healthy subjects
Subjects 30 healthy subjects
Designs
Experimental procedure
1 The experiments will be carried out twice once with laser intervention and once with sham The experiment time was 25 minutes and both were scheduled between 330 and 500 PM The room temperature was controlled between 25-27 degrees The interval between two experiments is between one to two weeks to avoid the influence of seasonal factors
2 Before the experiment the subjects Ryodoraku value will be measured The subjects shall sit in a fixed posture and step on the square box at room temperature and avoid touching metal or cold materials
3 Before the start of the experiment ask the subject to hold the hand-held heart rate measurement device and teach him how to use it set up the laser acupuncture head on the sleep acupoints we used then blindfold him with a blinder
4 From 0 to 5 minutes let the subject measure the first HRV parameters as the data before intervention
5 From the 5th to 10th minute of the experiment the laser or sham intervenes at the eighth minute and the intervention time lasts for ten minutes
6 From the 10th to 15th minute the subject measured the second time HRV parameters which was used as the data of the during the intervention
7 In the 15th to 20th minutes the laser or sham will end the intervention at the 17th to 18th minutes
8 From the 20th to 25th minute of the experiment the subject measured the third heart rate variability parameters under blindfolded conditions as the data of the after the intervention
9 Take off his blinder Ask the subject to measure Ryodoraku value again and end the experiment
Sham intervention method The subject in blindfolded state can hear the same prompt sound as laser acupuncture but does not irradiate light Fig3-4
Experiment B All procedures are the same as Experiment A but the light source is change to LED wearable devices Fig5-6
STAGE 2
Participant Subjects 120 insomnia subjects 80 subjective insomnia 40 objective insomnia
Designs
Experimental procedure
Prepare period
1 Inform the subjects of the research process complete questionnaire such as PSQI MEQ ISI ESS and limb motor sensory survey to determine whether they are eligible for the study
2 The subject fills in the sleep diary for one week and wears an oximeter to confirm that there is no sleep abnormality
3 The subject used a tiny wireless sleep physiological recorder to record the quality of sleep for two nights The first night was the adaptation period and was not included in the analysis and the sleep data of the second night was included in the analysis base line
Experimental period
1 DAY0 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
2 DAY1 The subject filled out the rest of the questionnaires and then asked them to complete the Ryodoraku measurement and wear the TD1 tiny PSG recorder to perform the first multi-channel physiological measurement explain the use process of the wearable light therapy deivce and let them download the EncephalApp stroop test Program
3 DAY15 All procedures are the same as DAY1 but no questionnaires second tiny PSG record
4 DAY30 All procedures are the same as DAY1 fill questionnaires like PSQI ISI etc third tiny PSG record
5 DAY31-DAY36 take a break and do nothingwash-out
6 DAY37 All procedures are the same as DAY1 fourth tiny PSG record
7 DAY52 All procedures are the same as DAY15 fifth tiny PSG record
8 DAY67 All procedures are the same as DAY30 sixth tiny PSG record
9 DAY68 The subject returned the wearable light therapy device and TD1 recorder and confirmed whether the data of TD1 is complete Fig 7
Analysis Methods The main data is expressed in terms of mean and standard deviation SD The before -after difference in same groups is analyzed by t-test and the difference between groups is also analyzed by ANOVA
In the past there are no studies on using light acupuncture during the first sleep cycle or bed-time So we have the following hypotheses First irradiating low level light on the sleep acupoints during these periods will strengthen the activity of the parasympathetic during these periods Second the activity of the parasympathetic will improve the quality of sleep in the first sleep cycle because the parasympathetic activity of sleep onsetSO is an indicator of sleep quality Third the improvement of sleep quality in the first sleep cycle will affect the quality of total sleep and daytime cognitive functions I divide the research hypotheses for details into three categories
Part 1 To observe the relationship between light stimulation of traditional Chinese medicine TCM sleep-aiding acupoints
Hypothesis 1-1 After the laser stimulates the sleep-aiding acupoints the energy of the meridian that is too high will decrease and the energy of the meridian that is too low will increase
Hypothesis 1-2 After laser acupuncture the qi of the meridians will not be consumed too quickly like acupuncture so the needle retention is safe
Hypothesis 1-3 The efficacy of LED stimulation of acupoints should be similar to that of laser acupuncture
Part 2 Assumptions Related to Optical Design
Hypothesis 2-1 The most suitable light specifications for dark-skinned people are different from light-skinned people
Hypothesis 2-2 Some new optical components have good performance in light transmission Hypothesis 2-3 The newly designed light penetration experiment can obtain optical parameters more accurately and quickly
Part 3 Heart Rate Variability and Sleep Improvement
Hypothesis 3-1 We could improve parameters of heart rate variability by using the wearable light therapy device
Hypothesis 3-2 Optimizing HRV parameters before going to bed can improve the quality of the first sleep cycle
Hypothesis 3-3 After using a wearable light therapy device to improve the first sleep cycle it can also enhance the whole night sleep quality
Hypothesis 3-4 Improved sleep quality from using wearable light therapy device can lead to the improvements in daily cognitive function
Significance If this study is successfully proved to improve the sleep quality of insomnia patients it will give insomnia patients a treatment option other than sleep pills make light therapy be widely applied to the home environment and make researchers pay more attention to the possibility of using TCM procedure in the first sleep cycle
Research Materials and Equipment Research Methods
STAGE 1
Participant
Experiment A
A preliminary experiment of laser acupuncture on sleep acupoints healthy subjects
Subjects 30 healthy subjects
Designs
Experimental procedure
1 The experiments will be carried out twice once with laser intervention and once with sham The experiment time was 25 minutes and both were scheduled between 330 and 500 PM The room temperature was controlled between 25-27 degrees The interval between two experiments is between one to two weeks to avoid the influence of seasonal factors
2 Before the experiment the subjects Ryodoraku value will be measured The subjects shall sit in a fixed posture and step on the square box at room temperature and avoid touching metal or cold materials
3 Before the start of the experiment ask the subject to hold the hand-held heart rate measurement device and teach him how to use it set up the laser acupuncture head on the sleep acupoints we used then blindfold him with a blinder
4 From 0 to 5 minutes let the subject measure the first HRV parameters as the data before intervention
5 From the 5th to 10th minute of the experiment the laser or sham intervenes at the eighth minute and the intervention time lasts for ten minutes
6 From the 10th to 15th minute the subject measured the second time HRV parameters which was used as the data of the during the intervention
7 In the 15th to 20th minutes the laser or sham will end the intervention at the 17th to 18th minutes
8 From the 20th to 25th minute of the experiment the subject measured the third heart rate variability parameters under blindfolded conditions as the data of the after the intervention
9 Take off his blinder Ask the subject to measure Ryodoraku value again and end the experiment
Sham intervention method The subject in blindfolded state can hear the same prompt sound as laser acupuncture but does not irradiate light Fig3-4
Experiment B All procedures are the same as Experiment A but the light source is change to LED wearable devices Fig5-6
STAGE 2
Participant Subjects 120 insomnia subjects 80 subjective insomnia 40 objective insomnia
Designs
Experimental procedure
Prepare period
1 Inform the subjects of the research process complete questionnaire such as PSQI MEQ ISI ESS and limb motor sensory survey to determine whether they are eligible for the study
2 The subject fills in the sleep diary for one week and wears an oximeter to confirm that there is no sleep abnormality
3 The subject used a tiny wireless sleep physiological recorder to record the quality of sleep for two nights The first night was the adaptation period and was not included in the analysis and the sleep data of the second night was included in the analysis base line
Experimental period
1 DAY0 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
2 DAY1 The subject filled out the rest of the questionnaires and then asked them to complete the Ryodoraku measurement and wear the TD1 tiny PSG recorder to perform the first multi-channel physiological measurement explain the use process of the wearable light therapy deivce and let them download the EncephalApp stroop test Program
3 DAY15 All procedures are the same as DAY1 but no questionnaires second tiny PSG record
4 DAY30 All procedures are the same as DAY1 fill questionnaires like PSQI ISI etc third tiny PSG record
5 DAY31-DAY36 take a break and do nothingwash-out
6 DAY37 All procedures are the same as DAY1 fourth tiny PSG record
7 DAY52 All procedures are the same as DAY15 fifth tiny PSG record
8 DAY67 All procedures are the same as DAY30 sixth tiny PSG record
9 DAY68 The subject returned the wearable light therapy device and TD1 recorder and confirmed whether the data of TD1 is complete Fig 7
Analysis Methods The main data is expressed in terms of mean and standard deviation SD The before -after difference in same groups is analyzed by t-test and the difference between groups is also analyzed by ANOVA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None