The Effect of Avnace eZZe on Sleep Improvement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTCI Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Avance eZZe drink
Dietary supplement25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
Avance eZZe drink (without liposomal)
Dietary supplement25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
Placebo drink
Dietary supplement25 mL liquid sachet, 1 sachet/day, consume 1 sachet of the sample 1 hour before sleep daily
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Avance eZZeExperimental treatment 1 intervention
Group B: Avance eZZe (without liposomal)Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep monitoring
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Time frame
Day-0 (baseline), Day-1, Day-14, Day-282
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.
Time frame
Day-0 (baseline), Day-14, Day-283
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.
Time frame
Day-0 (baseline), Day-14, Day-28Secondary outcomes
1
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.
Time frame
Day-0 (baseline), Day-14, Day-282
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.
Time frame
Day-0 (baseline), Day-14, Day-283
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.
Time frame
Day-0 (baseline), Day-14, Day-284
Low Frequency/High Frequence (LF/HF) ratio
A sleep monitoring system will be utilized to measure LF/HF ratio.
Time frame
Day-0 (Baseline), Day-1, Day-14, Day-28Sponsors and contacts
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Source ClinicalTrials.gov