Occupational StressNCT07910279
Curcumin Nano Patch and Autonomic Function in Shift-Working Healthcare Professionals
A study testing Curcumin Nano Patch in people with Occupational Stress and Sleep Quality, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Sleep Quality
- What is being tested?
- Curcumin Nano Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20 to 60 years, of any sex, with full capacity to provide informed consent.
- Current clinical healthcare professionals working in relevant units at Shuang Ho Hospital who perform shift work, including evening or night shifts, and are exposed to sustained occupational stress.
- In generally good physical and mental health, without severe acute illness, and able to wear physiological monitoring equipment and follow study procedures.
- Willing to use the HRV monitoring device and study patches, complete questionnaires and diaries, and provide written informed consent.
Who cannot join
- Current or previous major psychiatric illness, such as severe depression, bipolar disorder or schizophrenia, or current treatment with antidepressants, anxiolytics or other psychiatric medications that may affect autonomic function or interfere with study assessments.
- Known clinically significant arrhythmia, including atrial fibrillation or atrioventricular block; an implanted cardiac pacemaker; or severe cardiovascular disease, including uncontrolled hypertension or heart failure.
- Frequent or long-term use of hypnotics or sedatives, including benzodiazepines or Z-drugs, or other medications that may substantially affect sleep or HRV, such as beta blockers.
- Known allergy to adhesive materials, turmeric, plants in the ginger family or related patch ingredients; or severe eczema, wounds or other skin conditions that make patch application unsuitable.
- Pregnancy or breastfeeding. Participants who become pregnant during the study discontinue further participation.
- Other conditions judged by the research team to make participation unsuitable, including inability to complete study procedures, anticipated prolonged leave or departure from shift work, or plans for major changes in daily routines within the two weeks before study initiation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
About this study
Official title: Development of a Portable Autonomic Sensing System for Physiological-Psychological Health Risk Prediction
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.
Read the detailed description
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.
- Conditions
- Occupational Stress, Sleep Quality
- Being tested
- Curcumin Nano Patch, Cooling Control Patch (Placebo)
- Keywords
- Heart Rate Variability, Curcumin, Shift Work, Healthcare Professionals, Wearable Monitoring, Crossover Study
- Medical subject headings
- Occupational Stress, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin Nano PatchOther
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.
Cooling Control Patch (Placebo)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Patch Followed by Cooling Control Patch | Experimental | 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. Receives: Other: Curcumin Nano Patch; Other: Cooling Control Patch (Placebo) |
| Cooling Control Patch Followed by Curcumin Patch | Experimental | 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. Receives: Other: Curcumin Nano Patch; Other: Cooling Control Patch (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Secondary outcomes (4)
Perceived Stress Scale (PSS) Score
Self-reported perceived stress assessed using the Perceived Stress Scale. Scores and changes from the beginning to the end of each intervention period are compared within participants between curcumin and cooling control patch conditions. Higher scores indicate greater perceived stress.
Measured: 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) Score
Self-reported sleep quality assessed using the Pittsburgh Sleep Quality Index. Scores and changes from the beginning to the end of each intervention period are compared within participants between curcumin and cooling control patch conditions. Higher scores indicate poorer sleep quality.
Measured: 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.
Generalized Anxiety Disorder-7 (GAD-7) Score
Self-reported anxiety symptoms assessed using the GAD-7 questionnaire. Scores and changes from the beginning to the end of each intervention period are compared within participants between curcumin and cooling control patch conditions. Higher scores indicate more severe anxiety symptoms.
Measured: 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.
Patient Health Questionnaire-9 (PHQ-9) Score
Self-reported depressive symptoms assessed using the PHQ-9 questionnaire. Scores and changes from the beginning to the end of each intervention period are compared within participants between curcumin and cooling control patch conditions. Higher scores indicate more severe depressive symptoms.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Mar 2026
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized to one of two treatment sequences: curcumin patch followed by cooling control patch, or cooling control patch followed by curcumin patch. Each treatment period lasts at least 14 days. The two treatment periods are separated by a washout of at least 14 days. Each participant receives both interventions.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lung Chan, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910279
- Sponsor's protocol ID
- NSTC-114-2622-E-038-004
- Other IDs
- 114WFD2011146
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Portable Autonomic Sensing System for Physiological-Psychological Health Risk Prediction
- ClinicalTrials.gov ID
- NCT07910279
- Acronym / sponsor ID
- NSTC-114-2622-E-038-004
- Conditions
- Occupational Stress, Sleep Quality
- Keywords
- Heart Rate Variability, Curcumin, Shift Work, Healthcare Professionals, Wearable Monitoring, Crossover Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two treatment sequences: curcumin patch followed by cooling control patch, or cooling control patch followed by curcumin patch. Each treatment period lasts at least 14 days. The two treatment periods are separated by a washout of at least 14 days. Each participant receives both interventions.
| Arm | Type | Receives |
|---|---|---|
| Curcumin Patch Followed by Cooling Control Patch | Experimental | Other: Curcumin Nano Patch, Other: Cooling Control Patch (Placebo)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. |
| Cooling Control Patch Followed by Curcumin Patch | Experimental | 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 20 to 60 years, of any sex, with full capacity to provide informed consent.
- Current clinical healthcare professionals working in relevant units at Shuang Ho Hospital who perform shift work, including evening or night shifts, and are exposed to sustained occupational stress.
- In generally good physical and mental health, without severe acute illness, and able to wear physiological monitoring equipment and follow study procedures.
- Willing to use the HRV monitoring device and study patches, complete questionnaires and diaries, and provide written informed consent.
Key exclusion criteria (6 listed)
- Current or previous major psychiatric illness, such as severe depression, bipolar disorder or schizophrenia, or current treatment with antidepressants, anxiolytics or other psychiatric medications that may affect autonomic function or interfere with study assessments.
- Known clinically significant arrhythmia, including atrial fibrillation or atrioventricular block; an implanted cardiac pacemaker; or severe cardiovascular disease, including uncontrolled hypertension or heart failure.
- Frequent or long-term use of hypnotics or sedatives, including benzodiazepines or Z-drugs, or other medications that may substantially affect sleep or HRV, such as beta blockers.
- Known allergy to adhesive materials, turmeric, plants in the ginger family or related patch ingredients; or severe eczema, wounds or other skin conditions that make patch application unsuitable.
- Pregnancy or breastfeeding. Participants who become pregnant during the study discontinue further participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin Nano PatchA 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. | Other | Cooling Control Patch Followed by Curcumin Patch, Curcumin Patch Followed by Cooling Control Patch |
| Cooling Control Patch (Placebo)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. | Other | Cooling Control Patch Followed by Curcumin Patch, Curcumin Patch Followed by Cooling Control Patch |
Primary outcome
Standard Deviation of Normal-to-Normal Intervals (SDNN)
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.
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.
Root Mean Square of Successive Differences Between Normal-to-Normal Intervals (RMSSD)
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.
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.
Low-Frequency Power of Heart Rate Variability (LF)
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.
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.
High-Frequency Power of Heart Rate Variability (HF)
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.
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.
Ratio of Low-Frequency to High-Frequency Power (LF/HF)
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.
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.
4 secondary outcomes
Perceived Stress Scale (PSS) Score
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) Score
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.
Generalized Anxiety Disorder-7 (GAD-7) Score
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.
Patient Health Questionnaire-9 (PHQ-9) Score
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lung Chan principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Nano Patch in people with Occupational Stress and Sleep Quality, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Normal-to-Normal Intervals (SDNN) (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.