28 Day
Sleep Quality Enhancement Protocol
| STUDY TITLE | Sleep Quality Enhancement Protocol |
|---|---|
| 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 |
Matthew Amsden, Ivan Fedkiv, Challenge Author |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Participants will incorporate SleepWhale Natural Sleep Drops into their nightly routine for four weeks. They will focus on establishing a consistent sleep schedule and environment to potentially enhance sleep quality. Participants will provide qualitative feedback on their overall sleep experiences and perceived improvements. |
| 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 |
SleepWhale Natural Sleep Drops: $97
|
| Outcome measures |
PROMIS Sleep Disturbance Scale |
| 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 disturbances are a pervasive issue for many adults in the United States, impacting daily life and overall well-being. While academic research supports the benefits of natural sleep aids like melatonin, social media is buzzing with testimonials about the effectiveness of sleep drops for better rest. This study seeks to bridge the gap between anecdotal claims and scientific evidence by incorporating SleepWhale Natural Sleep Drops into participants' routines. By evaluating changes in sleep quality using the PROMIS Sleep Disturbance Scale, this study aims to validate or refute the popular belief that natural sleep supplements can significantly enhance sleep. It's crucial to run this study to provide clarity and guidance for those seeking non-pharmaceutical sleep solutions.
My Objective for You:
My objective for you, as a participant, is to help you establish a consistent sleep schedule and environment using SleepWhale Natural Sleep Drops, aiming for measurable improvements in your sleep quality. By the end of four weeks, you'll gain insights into your sleep patterns and potentially experience enhanced rest, as documented by the PROMIS Sleep Disturbance Scale.
Aims & Objectives:
This study aims to assess the impact of SleepWhale Natural Sleep Drops on sleep quality over a four-week period. The objective is to measure improvements using the PROMIS Sleep Disturbance Scale and gather qualitative feedback on participants' sleep experiences.
Significance & Impact:
By investigating the potential benefits of SleepWhale Natural Sleep Drops, this study could offer a scientifically-backed alternative for improving sleep quality, addressing a widespread concern for many adults. Expected outcomes include enhanced sleep quality and valuable insights into non-pharmaceutical interventions. Limitations may include individual variability in sleep responses and adherence to the protocol.
The Intervention
Included Products & Services
Product Name: SleepWhale Natural Sleep Drops
Quantity included: 1
Price: $97.00
Product Description: A melatonin alternative. Crafted with natural herbs and minerals that target the most critical parts of the sleep journey for your best next-day self.
Product Image:
Ingredients:
Broad-spectrum nano-hemp (0.00% THC)
CBN isolate
Suntheanine (a form of L-theanine)
Gadomag+
M2 Lion's Mane
Sibelius (a proprietary Roman chamomile extract)
Product Safety: