Sleep Disorder (Disorder)NCT07172607
The Effect of Avnace eZZe on Sleep Improvement
A study testing Avance eZZe drink and Avance eZZe drink (without liposomal) in people with Sleep Disorder (Disorder) and Anxiety Depression Disorder, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder (Disorder), Anxiety Depression Disorder
- What is being tested?
- Avance eZZe drink and Avance eZZe drink (without liposomal)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18 years or older;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder;
- Regular bedtime, between 21:00 and 01:00 and regular wake time;
- Insomnia Severity Index (ISI) score ≥15;
- All medications or interventions for insomnia, mental or physical disorders must have been stable for at least four weeks prior to screening, and participants had to be willing to maintain a stable regimen 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.
Who cannot join
- A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder;
- Depressive symptoms at screening were considered significantly severe with a PHQ-9 score > 14
- Anxiety symptoms at screening were considered significantly severe with a GAD-7 score > 15;
- Females who are breastfeeding or pregnant;
- Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.);
- Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study;
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- History of drug or alcohol dependency or abuse within approximately the previous 2 years;
- Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological, or psychiatric disease or malignancy or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments;
- Scheduled for major surgery during the study;
- Participants known to be allergic to any components of the product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Hsin-Chien Lee, Doctor, +886-02-22490088 ext. 79213/8158, ellalee@tmu.edu.tw
About this study
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.
- Being tested
- Avance eZZe drink, Avance eZZe drink (without liposomal), Placebo drink
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance eZZe drinkDietary supplement
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
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 drinkDietary supplement
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
| Study group | Role | What they receive |
|---|---|---|
| Avance eZZe | Experimental | Not described Receives: Dietary Supplement: Avance eZZe drink |
| Avance eZZe (without liposomal) | Active comparator | Not described Receives: Dietary Supplement: Avance eZZe drink (without liposomal) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep monitoring
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Measured: 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.
Measured: 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.
Measured: Day-0 (baseline), Day-14, Day-28
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day-0 (Baseline), Day-1, Day-14, Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start9 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsin-Chien Lee, Doctor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172607
- Sponsor's protocol ID
- N202505031
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Avnace eZZe on Sleep Improvement
- ClinicalTrials.gov ID
- NCT07172607
- Acronym / sponsor ID
- N202505031
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avance eZZe | Experimental | Dietary Supplement: Avance eZZe drink |
| Avance eZZe (without liposomal) | Active comparator | Dietary Supplement: Avance eZZe drink (without liposomal) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age 18 years or older;
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder;
- Regular bedtime, between 21:00 and 01:00 and regular wake time;
- Insomnia Severity Index (ISI) score ≥15;
- All medications or interventions for insomnia, mental or physical disorders must have been stable for at least four weeks prior to screening, and participants had to be willing to maintain a stable regimen throughout the study;
Key exclusion criteria (10 listed)
- A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder;
- Depressive symptoms at screening were considered significantly severe with a PHQ-9 score > 14
- Anxiety symptoms at screening were considered significantly severe with a GAD-7 score > 15;
- Females who are breastfeeding or pregnant;
- Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avance eZZe drink25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily | Dietary supplement | Avance eZZe |
| Avance eZZe drink (without liposomal)25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily | Dietary supplement | Avance eZZe (without liposomal) |
| Placebo drink25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily | Dietary supplement | Placebo |
Primary outcome
Sleep monitoring
Time frame: Day-0 (baseline), Day-1, Day-14, Day-28
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Sleeping quality
Time frame: Day-0 (baseline), Day-14, Day-28
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.
Insomnia Severity
Time frame: Day-0 (baseline), Day-14, Day-28
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.
4 secondary outcomes
General level of daytime sleepiness
Time frame: Day-0 (baseline), Day-14, Day-28
Depression severity
Time frame: Day-0 (baseline), Day-14, Day-28
Anxiety severity
Time frame: Day-0 (baseline), Day-14, Day-28
Low Frequency/High Frequence (LF/HF) ratio
Time frame: Day-0 (Baseline), Day-1, Day-14, Day-28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsin-Chien Lee, Doctor principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance eZZe drink and Avance eZZe drink (without liposomal) in people with Sleep Disorder (Disorder) and Anxiety Depression Disorder, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Chien Lee, Doctor (+886-02-22490088 ext. 79213/815, ellalee@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep monitoring (time frame: Day-0 (baseline), Day-1, Day-14, Day-28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.