A Personalized Trial is an experiment conducted within one individual. Each Personalized Trial is designed like a clinical study, providing a schedule and all the tools necessary to help you understand how a particular treatment may impact you. In the Personalized Trial to Improve Sleep Quality, we willsend you two doses of melatonin to try while we ask questions about how you feel each day. We willalso send you an activity monitor to track any impact melatonin may have on your sleep and activity. Atthe end of the study, we will send you a report of the data we observed.

The purpose of this study is to test out the methods researchers use to virtually enroll participants, and to test out the methods used to assess participant symptoms in response to a health and wellness strategy. In this case, we are using melatonin. We are interested in your overall satisfaction with this process to inform future Personalized Trials.

One possible benefit of participation in this study may be that participants may learn whether or not melatonin works for them as a way to improve their sleep quality.

This Personalized Trial is for adults ages 18+ who suffer from poor sleep quality.

After confirmation of eligibility and informed consent, study participants will compare the effectiveness of two different doses of melatonin. In all, the study will last 14-weeks. This is a 100% at-home virtual study: there are no in-person visits involved.

First, a two-week baseline period will occur, where participants will closely track their activity and sleep using a Fitbit and online surveys texted to your smartphone. After the baseline period, participants will receive a schedule instructing them when to take pills. Some weeks, participants will be instructed to take 3 mg dose melatonin, .5 mg dose melatonin, or placebo. Participants will not know which dose of melatonin or placebo they are taking during the study. Each day, we will ask similar survey questions and participants will continue to wear their Fitbit all day and all night.

There are minimal risks to study participation, and participants may benefit from learning about how melatonin affects them.

Participants will receive a personalized summary of their responses to melatonin, revealing when they were taking each dose of melatonin or placebo during the trial, which can help them decide how to involve melatonin in their personal wellness strategy. Participants will be able to keep the Fitbit used for their Personalized Trial. Participants who complete the satisfaction survey and return their 3 study pill bottles will also receive a $100 ClinCard as a thank you for their participation.

No, we will send you all of the materials needed to participate in the study including 1 Fitbit, 3 pill bottles, and the supplements.

If you have any questions about this study, please contact the Institute of Health System Science team at personalizedtrials@northwell.edu, or call us at 646-864-6020.