The Effect of Avnace eZZe on Sleep Improvement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Avance eZZe drink, Avance eZZe drink (without liposomal), Placebo drink.
- Who it may be relevant to
- Registry conditions: Sleep Disorder (Disorder), Anxiety Depression Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Avance eZZe drink
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily - Dietary supplement 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 Placebo drink
25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
Primary outcome measures
- Sleep monitoring [Time frame: Day-0 (baseline), Day-1, Day-14, Day-28]
- Sleeping quality [Time frame: Day-0 (baseline), Day-14, Day-28]
- Insomnia Severity [Time frame: Day-0 (baseline), Day-14, Day-28]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Medical University — Taipei
Identifiers
NCT: NCT07172607 · N202505031