A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes (NCT07600528) | Clinical Trial Compass
CompletedNot Applicable
A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes
China17 participantsStarted 2024-04-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 44 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
* Adult participant with mild to moderate sleep disturbance.
* Able and willing to use the wearable sleep monitoring device according to study instructions.
* Able to maintain normal diet and routine habits during the study.
* Able to avoid alcohol during the study period.
* Able to avoid excessive exercise 2 hours before sleep during test nights.
* Able to take the assigned product with warm water 1 hour before sleep during test nights.
* Willing to complete the full study procedures and provide sleep monitoring data.
Exclusion Criteria:
* Known allergy or hypersensitivity to the study product, comparator product, or any related ingredients.
* Severe sleep disorder or other condition judged by the investigator to make participation inappropriate.
* Acute or chronic illness that could affect sleep assessment or participant safety.
* Use of medications, supplements, or procedures that could affect sleep outcomes during the study period.
* Alcohol intake or other behavior likely to interfere with sleep testing.
* Inability to use the wearable monitoring device or mobile application as required.
* Serious protocol deviation or inability to tolerate the test food.
* Any factor that could seriously affect study results.
* Any other reason judged by the investigator to require withdrawal or exclusion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Deep Sleep Duration Between NatureU Sweet Dream and Comparator Product