Sleep Gummy for Sleep Quality
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if a melatonin-free sleep gummy (a chewable dietary supplement) improves sleep in children aged 4 to 16 whose parents report sleep concerns. It will also learn about the safety and tolerability of the gummy. The main questions it aims to answer are:
1. Does the gummy improve the child's sleep disturbance, compared with a look-alike gummy?
2. Does the gummy change daytime problems linked to poor sleep, sleep habits, and the parent's overall impression of the child's sleep?
3. What medical problems do children have when taking the gummy?
Researchers will compare the sleep gummy to a placebo (a look-alike gummy that contains no active ingredient) to see if the sleep gummy improves sleep.
Participants will:
1. Complete about 1 week of baseline questionnaires and diaries, then take 2 gummies once a day in the evening for 4 weeks, with a parent or guardian supervising
2. Take part from home, with no clinic visits, using the Chloe study app
3. Answer sleep questionnaires every week, a sleep habits questionnaire every 2 weeks, and a safety survey every week
4. Have a parent or guardian keep a daily diary of sleep, naps, mood, activity, and the time the gummies were taken
5. Some participants (an optional group of 60) will also wear a wrist device (a fitness tracker/smartwatch) at night to measure sleep
Who Is on the Research Team?
Noah Craft, MD, PhD
Principal Investigator
People Science, Inc.
Are You a Good Fit for This Trial?
This trial is for children ages 4 to 16 whose parents are concerned about their sleep, such as trouble falling asleep or restless nights. Children must be able to take gummies and have a parent or guardian help with study tasks at home.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Olly melatonin-free supplement
Trial Overview
The study compares a melatonin-free sleep gummy supplement to a placebo (inactive) gummy in children. Participants will take the gummies daily for four weeks at home while tracking sleep and related behaviors using an app and questionnaires.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Under parent/guardian supervision, participant takes 2 gummies once per evening for 4 weeks.
Under parent/guardian supervision, participants 2 gummies oncer per evening for 4 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Olly, PBC
Lead Sponsor
People Science, Inc.
Industry Sponsor
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