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A Single-Center, Open-Label, Exploratory Self-Controlled Study of NatureU Sweet Dream on Deep Sleep Duration and Deep Sleep Percentage in Adults With Sleep Disturbance

ClinicalTrials.gov · COMPLETED, 2024

17 participants

Abstract

This was a single-center, open-label, exploratory self-controlled study evaluating NatureU Sweet Dream on sleep outcomes in adults with mild to moderate sleep disturbance. Seventeen participants were enrolled, 2 participants were lost to follow-up, and 15 participants provided valid effectiveness data. Participants completed two independent test-food sessions using wearable sleep monitoring. The comparator session used a commercially available melatonin product, and the test-product session used NatureU Sweet Dream. The main outcomes were deep sleep duration and deep sleep percentage measured by a wearable device and exported through the Huawei Health application. No adverse reactions were reported during the study.

Conditions: Sleep Disturbance, Sleep Quality.

Primary outcome: Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product.

Enrollment: 17 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 17 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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