An interventional study of Curcumin Nano Patch and Cooling Control Patch (Placebo) in Occupational Stress and Sleep Quality, sponsored by Taipei Medical University Shuang Ho Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Supportive care
This randomized, open-label, placebo-controlled crossover study compares a curcumin-containing patch with a cooling placebo patch without curcumin in healthcare professionals who work rotating shifts. It evaluates heart rate variability, stress, sleep quality, anxiety and depressive symptoms, and examines the relationships between wearable measurements and questionnaire scores.
Participants are healthcare professionals aged 20 to 60 years at Taipei Medical University Shuang Ho Hospital in Taiwan. Each participant receives both patches in randomly assigned order. Each patch is used for at least 14 days, for 8 hours per day, with a washout of at least 14 days between periods. Participants and researchers know which patch is used. Wearable measurements are compared within the same participant across the two patch periods. Questionnaires are completed at the beginning and end of each period.
This is a single-center, randomized, open-label, placebo-controlled, two-sequence crossover study conducted among shift-working healthcare professionals at Taipei Medical University Shuang Ho Hospital. The objectives are to compare the two patch conditions using wearable heart rate variability (HRV) and questionnaire measures, examine associations between HRV and self-reported stress and sleep, and assess wearable monitoring in a clinical shift-work setting.
Participants receive a nano-curcumin patch and a cooling placebo patch without active curcumin in randomly assigned order. Patches are applied to the trunk for 8 hours daily and replaced each day. Each intervention period lasts at least 14 days. A washout of at least 14 days without patches separates the periods. Participation lasts approximately 7 weeks. No masking is used.
The wearable device is the Leadtek amor H2 Plus ECG/HRV watch, model 8Z37. Participants are instructed to wear it during work and sleep, except during charging and cleaning. HRV collection begins 3 days before the first intervention. Daily resting recordings last 3 to 5 minutes; recordings during washout are optional. HRV parameters are SDNN, RMSSD, LF, HF and LF/HF.
The Perceived Stress Scale, Pittsburgh Sleep Quality Index, Generalized Anxiety Disorder-7 questionnaire and Patient Health Questionnaire-9 are administered at the beginning and end of each intervention period, giving four assessment occasions for each questionnaire. Daily diaries record sleep, work shifts, stress and fatigue. Research staff contact participants at least weekly. Participants report patch-site irritation, device discomfort and other symptoms and may withdraw at any time.
The original protocol, Version 1.1 dated November 24, 2025, includes paired comparisons, participant-level mixed-effects models, repeated-measures analysis of variance, transformation of skewed HRV data, time-by-intervention and covariate analyses, and exploratory relationships between HRV and questionnaire measures. It also includes day/night and longitudinal analyses and development of stress and sleep classification models with leave-one-subject-out validation.
The following participant-level analysis specifications were documented on October 19, 2026 during retrospective registration. For SDNN, RMSSD, LF and HF, available numeric records are averaged within each intervention period for each participant. For each participant and intervention period, LF/HF is calculated as mean LF divided by mean HF. Both means must be available and mean HF must be nonzero. The curcumin-period and placebo-period values are compared as paired observations. The main period comparison uses available recordings across each intervention period. Day/night subgroups are defined by recording time, without confirmation of actual sleep state.
An additional analysis expresses each participant's intervention-period value as a percentage of baseline. Baseline records comprise all available records from the last three recorded baseline dates before the first intervention, pooled with up to the final three available washout records between periods. Baseline SDNN, RMSSD, LF and HF are means of the selected records. Baseline LF/HF is the selected records' mean LF divided by their mean HF. If no eligible washout records are available, only pre-intervention records are used. The same participant-specific baseline is used for both conditions. The normalized value is 100 multiplied by the intervention-period value divided by the baseline value, calculated only when baseline is available and nonzero.
The finalized paired comparisons use the two-sided Wilcoxon signed-rank test for both raw participant-level period values and baseline-normalized values. Zero paired differences are excluded and tied absolute differences receive average ranks. P values use exhaustive sign enumeration for up to 20 nonzero pairs and 200,000 Monte Carlo sign assignments to ranks for larger samples, with a fixed reproducible seed. Participant-level values are summarized across participants as median (Q1, Q3). Each plotted dot represents one participant. The complete paired cohort and a subgroup with at least 10 recordings in each intervention period are analyzed separately. Multiple metric and subgroup comparisons are exploratory; p values are not adjusted for multiplicity.
A total of 51 participants were enrolled; 50 completed the study and one withdrew. Enrollment began on March 20, 2026, and wearable measurements began on April 4, 2026. All measurements and questionnaires were completed on October 15, 2026. No adverse events required further follow-up. Both the primary completion date and study completion date are October 15, 2026. This is a retrospective registration prepared after study completion.
236 studies on the registry are indexed under Occupational Stress; 63 are open to participants now.
This study's enrollment of 51 is below the median of 84 across 168 interventional studies indexed under Occupational Stress.
Browse Occupational Stress studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 102 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants use the curcumin nano patch for at least 14 days, followed by a washout of at least 14 days, and then the cooling control patch without curcumin for at least 14 days. Each patch is applied for 8 hours per day and replaced daily. No masking is used.
Other: Curcumin Nano Patch · Other: Cooling Control Patch (Placebo)
Participants use the cooling control patch without curcumin for at least 14 days, followed by a washout of at least 14 days, and then the curcumin nano patch for at least 14 days. Each patch is applied for 8 hours per day and replaced daily. No masking is used.
Other: Curcumin Nano Patch · Other: Cooling Control Patch (Placebo)
A topical patch containing nano-formulated curcumin as the active ingredient (BtNPN botanical nano-curcumin patch), supplied by Leadtek. One patch is applied to a designated area of the trunk for 8 hours daily and replaced each day for at least 14 days.
A cooling control patch without active curcumin, supplied by Leadtek. It provides a cooling sensation only and serves as the placebo comparator. One patch is applied to a designated area of the trunk for 8 hours daily and replaced each day for at least 14 days. No masking is used.
Standard Deviation of Normal-to-Normal Intervals (SDNN)
SDNN is the standard deviation of normal-to-normal intervals, expressed in milliseconds. For each participant, available SDNN recordings are averaged separately within the curcumin and cooling placebo periods. These two period means are compared as paired observations using the two-sided Wilcoxon signed-rank test. Baseline-normalized comparisons are additional analyses defined in the Detailed Description. The period-level comparison includes available recordings across each period, rather than a single resting or night-only measurement.
Time frame: Each of two intervention periods of at least 14 days, separated by at least 14 days of washout; approximately 7 weeks total. Additional baseline analysis uses 3 pre-intervention dates and up to 3 final washout records.
Root Mean Square of Successive Differences Between Normal-to-Normal Intervals (RMSSD)
RMSSD is the root mean square of successive differences between normal-to-normal intervals, expressed in milliseconds. For each participant, available RMSSD recordings are averaged separately within the curcumin and cooling placebo periods. These two period means are compared as paired observations using the two-sided Wilcoxon signed-rank test. Baseline-normalized comparisons are additional analyses defined in the Detailed Description. The period-level comparison includes available recordings across each period.
Time frame: Each of two intervention periods of at least 14 days, separated by at least 14 days of washout; approximately 7 weeks total. Additional baseline analysis uses 3 pre-intervention dates and up to 3 final washout records.
Low-Frequency Power of Heart Rate Variability (LF)
LF is HRV power in the 0.04-to-0.15-Hz frequency band. For each participant, available LF recordings are averaged separately within the curcumin and cooling placebo periods. These two period means are compared as paired observations using the two-sided Wilcoxon signed-rank test. Baseline-normalized comparisons are additional analyses defined in the Detailed Description. The period-level comparison includes available recordings across each period.
Time frame: Each of two intervention periods of at least 14 days, separated by at least 14 days of washout; approximately 7 weeks total. Additional baseline analysis uses 3 pre-intervention dates and up to 3 final washout records.
High-Frequency Power of Heart Rate Variability (HF)
HF is HRV power in the 0.15-to-0.4-Hz frequency band. For each participant, available HF recordings are averaged separately within the curcumin and cooling placebo periods. These two period means are compared as paired observations using the two-sided Wilcoxon signed-rank test. Baseline-normalized comparisons are additional analyses defined in the Detailed Description. The period-level comparison includes available recordings across each period.
Time frame: Each of two intervention periods of at least 14 days, separated by at least 14 days of washout; approximately 7 weeks total. Additional baseline analysis uses 3 pre-intervention dates and up to 3 final washout records.
Ratio of Low-Frequency to High-Frequency Power (LF/HF)
LF/HF is the dimensionless ratio of LF power (0.04-0.15 Hz) to HF power (0.15-0.4 Hz). For each participant and intervention period, LF/HF is calculated as mean LF divided by mean HF. Both means must be available and mean HF must be nonzero. The curcumin-period and cooling placebo-period ratios are compared as paired observations using the two-sided Wilcoxon signed-rank test. Baseline LF/HF uses the same ratio-of-means calculation on the selected baseline records; normalized comparisons are additional analyses defined in the Detailed Description.
Time frame: Each of two intervention periods of at least 14 days, separated by at least 14 days of washout; approximately 7 weeks total. Additional baseline analysis uses 3 pre-intervention dates and up to 3 final washout records.
10-Item Perceived Stress Scale (PSS-10) Total Score
Self-reported perceived stress is assessed using the 10-item Perceived Stress Scale (PSS-10). Each item is scored from 0 to 4. Items 4, 5, 7 and 8 are reverse-scored before the 10 item scores are summed. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (a worse outcome). Total scores and changes from the beginning to the end of each intervention period are compared within participants between the curcumin and cooling control patch conditions.
Time frame: At the beginning and end of each of the two intervention periods (4 assessments); each period lasts at least 14 days, with a washout of at least 14 days; approximately 7 weeks total.
Pittsburgh Sleep Quality Index (PSQI) Global Score
Self-reported sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). Seven component scores, each ranging from 0 to 3, are summed to produce a global score ranging from 0 to 21. Higher global scores indicate poorer sleep quality (a worse outcome). Global scores and changes from the beginning to the end of each intervention period are compared within participants between the curcumin and cooling control patch conditions.
Time frame: At the beginning and end of each of the two intervention periods (4 assessments); each period lasts at least 14 days, with a washout of at least 14 days; approximately 7 weeks total.
7-Item Generalized Anxiety Disorder (GAD-7) Total Score
Self-reported anxiety symptoms are assessed using the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire. Each item is scored from 0 to 3, and the seven item scores are summed to produce a total score ranging from 0 to 21. Higher total scores indicate more severe anxiety symptoms (a worse outcome). Total scores and changes from the beginning to the end of each intervention period are compared within participants between the curcumin and cooling control patch conditions.
Time frame: At the beginning and end of each of the two intervention periods (4 assessments); each period lasts at least 14 days, with a washout of at least 14 days; approximately 7 weeks total.
9-Item Patient Health Questionnaire (PHQ-9) Total Score
Self-reported depressive symptoms are assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, and the nine item scores are summed to produce a total score ranging from 0 to 27. Higher total scores indicate more severe depressive symptoms (a worse outcome). Total scores and changes from the beginning to the end of each intervention period are compared within participants between the curcumin and cooling control patch conditions.
Time frame: At the beginning and end of each of the two intervention periods (4 assessments); each period lasts at least 14 days, with a washout of at least 14 days; approximately 7 weeks total.
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