Olly, PBC
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
Each family takes part for up to about 11 weeks in total which includes a 1 week baseline period and a 4 week study product/placebo use period.
Inclusion Criteria: * Child is aged 4 to 16 years, inclusive, at screening. * Parent or legal guardian reports current concerns about the child's sleep (for example, difficulty falling asleep, staying asleep, or keeping a consistent sleep routine) and confirms the child has no diagnosed sleep disorder. * Parent or legal guardian can read and understand English. * Parent or legal guardian can read, understand, and give informed consent on behalf of the child; the child gives age-appropriate assent where applicable. * Parent or legal guardian can use a personal smartphone and download Chloe by…
Melatonin-free supplement intended for children who experience mild-to-moderate sleep concerns. Contains magnesium, l-theanine, lemon balm extract, and chamomile.
The placebo gummy matches the study product in appearance, flavor, texture, and packaging and contains no active ingredients.