28 Day
Night Shift: Evaluate Melatonin’s Sleep Boost
| STUDY TITLE | Night Shift: Evaluate Melatonin’s Sleep Boost |
|---|---|
| Submitted under umbrella | |
| Date submitted |
- |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Patrick Killen, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Unlock the secret to dreamy nights and energized days with our 28-day 'Night Shift' study. Dive into sleep like never before with nightly melatonin. Measure your transformation using the PROMIS Sleep Disturbance Scale and Neuro-QOL Fatigue Short Form. It's your ticket to revitalized mornings. U.S. adults: join now, before the sandman runs out of spots! |
| Participant engagement length |
28 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services | |
| Outcome measures |
PROMIS Sleep Disturbance Scale Neuro-QOL Item Bank v1.0 –Fatigue – Short Form |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this study:
Sleep quality and energy levels are crucial for daily functioning and overall health, yet many adults in the United States report difficulties in these areas. Research suggests that melatonin, a hormone that regulates sleep-wake cycles, may improve sleep quality and reduce fatigue. While social media buzzes with testimonials praising melatonin's benefits, scientific evidence remains mixed. This study will bridge the gap between anecdotal claims and empirical evidence to determine melatonin's true efficacy in enhancing sleep and boosting energy levels. It's vital to conduct this study to provide reliable information that can help individuals make informed decisions about their sleep health.
My Objective for You:
My objective for you is to empower you with evidence-based insights into how a nightly melatonin supplement affects sleep quality and energy levels, as measured by the PROMIS Sleep Disturbance Scale and the Neuro-QOL Fatigue Short Form, so you can make informed decisions about your sleep regimen and overall well-being.
Aims & Objectives:
The primary aim is to evaluate the effectiveness of a nightly melatonin supplement on improving sleep quality and reducing fatigue. The objective is to measure changes from baseline to the 30-day endpoint using validated self-assessment tools.
Significance & Impact:
This challenge has the potential to provide significant insights into the effectiveness of melatonin supplementation for improving sleep quality and energy levels. While positive outcomes could lead to better sleep health guidelines, limitations such as individual variability and placebo effects must be considered. By contributing to the body of knowledge, this study aims to guide evidence-based personal and clinical decisions regarding sleep health.