Our Science
Defined Sleep Increases Restorative Sleep In Humans With Insomnia
In a clinical trial, participants with insomnia received Placebo, Defined Sleep or CBD Alone in a random order, each for a period of one week. Participants were blinded to the treatment they received, and their sleep was measured using a wrist-worn sleep-tracking device made by Whoop.
Restorative Sleep is the combination of deep sleep and rapid eye movement (REM) sleep. Defined Sleep significantly increased the percentage of time that participants with insomnia spent in Restorative sleep. Shown above are examples of data from three individual participants from our clinical study.
Our Groundbreaking Sleep Study
At Defined Research, we’re committed to demonstrating clinical efficacy in our products. It’s foundational to our scientific approach, and a commitment to providing our customers with the highest level of trust & transparency.
In 2022 we completed a rigorous, double-blind, placebo-controlled trial of Defined Sleep’s patent-pending formula. This industry-first trial represents a landmark step in understanding CBD’s effects on human Restorative Sleep.
Trial participants consisted of ~125 insomnia-suffering adults selected from across the United States. Objective and subjective sleep data was collected via wearable technology and participant surveys, respectively. Importantly, the clinical trial was approved by an Institutional Review Board (IRB), which ensured the human study was governed in accordance with FDA regulations and can be published in peer-reviewed scientific journals.
The clinical trial was completed in July, 2022. Data analysis is ongoing, and the results from the study will be published in a peer-reviewed scientific journal. In two smaller clinical trials conducted in 2021 and early 2022, Defined Sleep significantly increased the percentage of time participants spent in Restorative Sleep.
Defined Research submitted an abstract to present the data from our clinical trial at The SLEEP Meeting in June 2023 in Indianapolis, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.
More details about the study are available at ClinicalTrials.gov.
Why Purity Matters
At Defined Research, we’re committed to delivering the highest level of formula purity in all of our ingredients. We’ve spent years carefully selecting and testing everything that goes into our product, and we lab-test every batch before it’s bottled. The result is that Defined Sleep contains the same, precise concentrations of active ingredients – consistently resulting in a better night’s sleep.
This rigorous approach is different than most CBD sleep products which are composed of extracts from hemp plants. The problem, for consumers, is that the specific contents of every extract can dramatically vary from batch to batch – just like wines from the same vineyard taste different each year.
Sleep & Beyond
Creating a solution for insomnia is just the first step in our scientific exploration of CBD’s wellness capabilities. We’re committed to discovering CBD formulas that provide valid pharmaceutical alternatives for a wide range of chronic human conditions. In addition to insomnia, we believe CBD promises substantial therapeutic benefits for anxiety, pain, arousal, inflammation and more. These will be the focus of our journey as we continue to expand and perfect our science.
Test Results
Defined Research tests every lot to ensure safety and quality standards are met. We use CBD isolate that is 99.9% pure to ensure each batch is exactly the same and has 0.0% THC. Our CBD isolate is from a GMP certified manufacturer using Colorado grown hemp.
Our third party testing is done at an ISO/IEC 17025:2005 accredited laboratory and recognized by the United States Food and Drug Administration (FDA) lab. All of our products are tested for Potency, Terpenes, Pesticides, Heavy Metals, Residual Solvents, Foreign Materials and Bacteria.