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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Avance eZZe drink with liposomal technology in improving sleep quality. The study aims to compare this drink to an Avance eZZe version without liposomal technology and a placebo. Participants include adults diagnosed with insomnia disorder who also have sleep and stress conditions. This interventional study will measure sleep quality, insomnia severity, and related factors over 28 days. Participants will be randomly assigned to one of three groups: Avance eZZe drink with liposomal technology, Avance eZZe drink without liposomal technology, or a placebo drink. Each participant will consume one 25 mL sachet of their assigned sample daily, one hour before bedtime, for 28 days. The study includes multiple assessment points at baseline (day 0), day 1, day 14, and day 28 to monitor changes during the intervention. During the study, participants will complete questionnaires assessing sleep disorders and stress conditions and use a sleep monitoring system to track sleep and autonomic nervous system conditions. Researchers will evaluate sleep quality, insomnia severity, daytime sleepiness, depression, anxiety, and autonomic balance using various measures at specified time points. Follow-up visits will ensure adherence and monitor safety throughout the 28-day period.
CONDITIONS
Brief 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 DSM-5 criteria for Insomnia Disorder
- Has a 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 before screening
- No use of sleep or stress-related supplements for at least four weeks before screening
- Willing and able to follow all study procedures
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 above 14
- Severe anxiety symptoms with GAD-7 score above 15
- Pregnant or breastfeeding females
- Females of childbearing potential not using acceptable pregnancy prevention methods
- Excessive caffeine use contributing to insomnia or unwillingness to avoid caffeine after 18:00 during the study
- History of drug or alcohol dependency or abuse within past two years
- Clinically significant diseases that could affect safety or study assessments
- Scheduled for major surgery during the study
- Known allergy to any study product components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants consume one 25 mL sachet of the assigned drink daily, one hour before sleep, for sleep improvement.
Visits on Day 0 (baseline), Day 1, Day 14, and Day 28
Trial Site Locations
Total: 1 location
1
Taipei Medical University
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hsin-Chien Lee, Doctor
P
Ping Lin
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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