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This study aims to examine the effectiveness of Avance eZZe drink with liposomal technology in improving sleep quality. Participants will be randomly assigned to either the placebo group, Avance eZZe drink group, and Avance eZZe drink without liposomal group, with 25 participants in each group. On the day of the experiment (day 0), participants are required to fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them 1 hour before sleep daily for 28 days. Follow-up assessments will be conducted in the day-1, day-14 and day-28, participants are required to fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avance eZZe | Experimental |
| |
| Avance eZZe (without liposomal) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avance eZZe drink | Dietary Supplement | 25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep monitoring | The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state. | Day-0 (baseline), Day-1, Day-14, Day-28 |
| Sleeping quality | The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome. | Day-0 (baseline), Day-14, Day-28 |
| Insomnia Severity | The Insomnia Severity Index (ISI) will be utilized to assess insomnia severity. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia. | Day-0 (baseline), Day-14, Day-28 |
| Measure | Description | Time Frame |
|---|---|---|
| General level of daytime sleepiness | The Epworth Sleepiness Scale (ESS) will be utilized to assess the general level of daytime sleepiness. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. | Day-0 (baseline), Day-14, Day-28 |
| Depression severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsin-Chien Lee, Doctor | Contact | +886-02-22490088 | 79213/815 | ellalee@tmu.edu.tw |
| Ping Lin | Contact | +886-02-87977811 | candice.lin@tci-bio.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsin-Chien Lee, Doctor | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Recruiting | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Avance eZZe drink (without liposomal) | Dietary Supplement | 25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily |
|
| Placebo drink | Dietary Supplement | 25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily |
|
Patient Health Questionnaire-9 (PHQ-9) will be utilized to assess depression level. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
| Day-0 (baseline), Day-14, Day-28 |
| Anxiety severity | Generalized Anxiety Disorder-7 (GAD-7) will be utilized to assess anxiety level. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity. | Day-0 (baseline), Day-14, Day-28 |
| Low Frequency/High Frequence (LF/HF) ratio | A sleep monitoring system will be utilized to measure LF/HF ratio. | Day-0 (Baseline), Day-1, Day-14, Day-28 |
| D001523 | Mental Disorders |