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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
Taipei Medical University
Taipei, Taiwan
RECRUITINGSleep monitoring
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Time frame: 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.
Time frame: 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.
Time frame: Day-0 (baseline), Day-14, Day-28
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.
Time frame: Day-0 (baseline), Day-14, Day-28
Depression severity
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.
Time frame: 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.
Time frame: 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.
Time frame: Day-0 (Baseline), Day-1, Day-14, Day-28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.