Effect of Low Level Light Irradiation on Insomniacs' Meridians During the First Sleep Cycle.
NCT05426226, Not applicable, Unknown, Taipei Veterans General Hospital, Taiwan
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Low Level Light Irradiation on Insomniacs' Meridians During the First Sleep Cycle. | ClinicalTrials.gov |
| NCT number | NCT05426226 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Taipei Veterans General Hospital, Taiwan | ClinicalTrials.gov |
| Conditions | Insomnia | ClinicalTrials.gov |
| Interventions | laser acupuncture, sham device | ClinicalTrials.gov |
| First posted | 2022-06-21 | ClinicalTrials.gov |
| Last updated | 2022-08-01 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Differences in sleep EEG before and after the laser irradiation compared to the sham group | Change from Baseline sleep EEG at 67 days | According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality | ClinicalTrials.gov |
| Primary | Differences in Heart rate variability before and after the laser irradiation compared to the sham group | Change from heart rate variability parameters at 67 days | 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. | ClinicalTrials.gov |
| Secondary | 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 | The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subje | ClinicalTrials.gov |
| Secondary | Differences in Visual Analogue Scale (VAS) before and after the laser irradiation compared to the sham group. | Change from Baseline VAS at 67 days | Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm). | ClinicalTrials.gov |
| Secondary | 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 | The Visual Stroop Test is designed to assess cognitive flexibility and attention span by examining a patient's ability to separate word and color naming stimuli through the use of three separate subtests. | ClinicalTrials.gov |
| Secondary | 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 | Designed as a brief screening tool for insomnia, the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia.The maximum total score is 28. | ClinicalTrials.gov |
| Secondary | 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 | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality. | ClinicalTrials.gov |
| Secondary | Differences in The Beck Depression Inventory II (BDI-II) before and after the laser irradiation compared to the sham group. | Change from Baseline BDI-II at 67 days | The Beck Depression Inventory II (BDI-II) is a 21-item, self-rated scale that evaluates key symptoms of depression. It rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. A higher score reflects greater symptoms of depression. | ClinicalTrials.gov |
| Secondary | Differences in Beck Anxiety Inventory (BAI) before and after the laser irradiation compared to the sham group. | Change from Baseline BAI at 67 days | the Beck Anxiety Inventory (BAI) is a 21-item, self-rated scale that evaluates anxiety levels , rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety.The maximum total score is 63.A higher score reflects greater anxiety. | ClinicalTrials.gov |
| Secondary | Differences in Chinese 14-item PSS before and after the laser irradiation compared to the sham group. | Change from Baseline PSS at 67 days | The PSS is an 14-item instrument designed to measure the perception of stress in a month . All items are rated on a 5-point Likert scale from 0 (never) to 4 (very often) and seven of them (4, 5, 6, 7, 9, 10, 13) are reverse-scored. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)