Avance eZZe drink for improving sleep in adults with insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional trial assigns adults with DSM-5 insomnia to one of three groups—Avance eZZe with liposomal technology, Avance eZZe without liposomes, or a placebo—with 25 participants per group. Participants complete baseline questionnaires and use a sleep monitoring system to record sleep and autonomic nervous system measures, then consume their assigned drink nightly one hour before bedtime for 28 days. Follow-up questionnaires and sleep monitoring are repeated on day 14 and day 28 to track changes in sleep quality and stress-related measures. Eligible participants must be 18 or older, have an Insomnia Severity Index score ≥15, maintain regular bed/wake times, and keep stable medications or interventions for at least four weeks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Medical University
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Hsin-Chien Lee, Doctor — Taipei Medical University
• Study coordinator: Hsin-Chien Lee, Doctor
• Email: ellalee@tmu.edu.tw
• Phone: +886-02-22490088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.