Actively Recruiting
The Effect of Avnace eZZe on Sleep Improvement
Led by TCI Co., Ltd. · Updated on 2026-02-04
75
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Avnace eZZe on Sleep Improvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 years or older
- Meets the DSM 5 criteria for Insomnia Disorder
- Regular bedtime between 21:00 and 01:00 and regular wake time
- Insomnia Severity Index (ISI) score of 15 or higher
- Stable medications or interventions for insomnia, mental or physical disorders for at least four weeks prior and willing to maintain stability throughout the study
- No consumption of sleep or stress-related supplements for at least four weeks prior to screening
- Willing and able to comply with all aspects of the protocol
You will not qualify if you...
- Current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, or circadian rhythm sleep disorder
- Severe depressive symptoms with PHQ-9 score greater than 14
- Severe anxiety symptoms with GAD-7 score greater than 15
- Females who are breastfeeding or pregnant
- Females of childbearing potential not using acceptable pregnancy prevention methods
- Excessive caffeine use contributing to insomnia or unwilling to avoid caffeine after 18:00 during the study
- History of drug or alcohol dependency or abuse within the last two years
- Clinically significant diseases that could affect safety or study assessments
- Scheduled for major surgery during the study
- Known allergy to any components of the product
AI-Screening
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Trial Site Locations
Total: 1 location
1
Taipei Medical University
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hsin-Chien Lee, Doctor
CONTACT
P
Ping Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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