Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07172607

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Taipei Medical University

Taipei, Taiwan, 110

Actively Recruiting

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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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