Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-29 @ 3:49 AM
Study NCT ID:
NCT05233761
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
Sponsor:
Defined Research
Organization:
Study Overview
Official Title:
Le Rêve 3.0: A Double-Blind, Placebo-Controlled, Randomized, Crossover Investigational Study to Determine if Defined CBD, a Capsule With a Custom Formulation of Cannabidiol (CBD) and Terpenes, Influences Sleep Physiology
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (\>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.
Detailed Description:
Our research study aims to test the effects of a highly purified CBD product on the structure and function of sleep physiology. In a survey by Consumer Reports, \~40% of adults who reported trying CBD said they used it to help them sleep, and a majority of those people said it worked. Nonetheless, to this date a rigorous, properly-controlled, and well-powered study to determine if CBD influences sleep physiology has simply never been reported in the scientific literature. The Le Rêve 3.0 study is designed to fill this important void in scientific knowledge.
We hypothesize that a novel CBD-based formulation in the form of an orally administered capsule will positively impact sleep physiology in subjects with insomnia. The capsule we will test is composed of \>99.9% purity hemp-derived CBD with a custom chemical formulation that also contains low concentrations (1 mg each) of highly purified (\>98%) forms of the terpenes linalool, myrcene, phytol, limonene, alpha-terpinene, alpha-terpineol, alpha-pinene, and beta-caryophyllene. Preclinical studies in animals have shown that these terpenes are sedating, but their potential effects on sleep physiology in humans have not been established. This product contains no detectable Delta-9-THC.
The Le Rêve 3.0 study will involve a cross-over design in which study participants will cycle through two independent treatments each for four weeks (Treatment 1: Placebo; Treatment 2: Defined CBD). The study participants will initially be randomized with respect to the treatment group, and all participants will be cycled through each of the two treatments. We will use a double-blind design in which the investigator and study participants will both be blinded to the treatments. Baseline data for each participant will be collected for two weeks prior to initiating treatments, as well as for a one-week washout period following each treatment arm. The entire study will last 12 weeks.
The primary objective of the study is to determine if Defined CBD influences objective measures of sleep physiology. Primary sleep physiology data will be obtained in a completely unbiased manner from a non-invasive sleep-tracking wristband, called "Whoop" (https://www.whoop.com), that electronically collects and transmits sleep data from study participants in the comfort of their own beds. The wristband collects hundreds of data points per second from a 3-axis accelerometer, 3-axis gyroscope, and heart rate sensor. The wristband can accurately measure latency to fall asleep, total sleep time, sleep fragmentation, as well as the time spent in each sleep stage \[Light, Slow Wave (Deep), Rapid Eye Movement (REM), and Awake\]. The wristband also collects data using photoplethysmography (PPG), a technique that involves measuring blood flow by assessing superficial changes in blood volume. Heart rate, heart rate variability, and respiratory rate, can all be derived from PPG data, and all of these metrics are used in Whoop's sleep detection and staging algorithms. Importantly, two recent publications, published independently from Whoop, show that data on sleep stages collected from the Whoop device are highly accurate and correlate well with polysomnography (PSG), the gold-standard of sleep tracking used in clinical studies conducted in sleep clinics.
The secondary objective of the study is to determine if Defined CBD influences subjective measures of sleep physiology. We will collect this subjective data from study participants in the form of a brief five-minute survey that will be completed on their smartphone at the end of each treatment period.
We hypothesize that a novel CBD-based formulation in the form of an orally administered capsule will positively impact sleep physiology in subjects with insomnia. The capsule we will test is composed of \>99.9% purity hemp-derived CBD with a custom chemical formulation that also contains low concentrations (1 mg each) of highly purified (\>98%) forms of the terpenes linalool, myrcene, phytol, limonene, alpha-terpinene, alpha-terpineol, alpha-pinene, and beta-caryophyllene. Preclinical studies in animals have shown that these terpenes are sedating, but their potential effects on sleep physiology in humans have not been established. This product contains no detectable Delta-9-THC.
The Le Rêve 3.0 study will involve a cross-over design in which study participants will cycle through two independent treatments each for four weeks (Treatment 1: Placebo; Treatment 2: Defined CBD). The study participants will initially be randomized with respect to the treatment group, and all participants will be cycled through each of the two treatments. We will use a double-blind design in which the investigator and study participants will both be blinded to the treatments. Baseline data for each participant will be collected for two weeks prior to initiating treatments, as well as for a one-week washout period following each treatment arm. The entire study will last 12 weeks.
The primary objective of the study is to determine if Defined CBD influences objective measures of sleep physiology. Primary sleep physiology data will be obtained in a completely unbiased manner from a non-invasive sleep-tracking wristband, called "Whoop" (https://www.whoop.com), that electronically collects and transmits sleep data from study participants in the comfort of their own beds. The wristband collects hundreds of data points per second from a 3-axis accelerometer, 3-axis gyroscope, and heart rate sensor. The wristband can accurately measure latency to fall asleep, total sleep time, sleep fragmentation, as well as the time spent in each sleep stage \[Light, Slow Wave (Deep), Rapid Eye Movement (REM), and Awake\]. The wristband also collects data using photoplethysmography (PPG), a technique that involves measuring blood flow by assessing superficial changes in blood volume. Heart rate, heart rate variability, and respiratory rate, can all be derived from PPG data, and all of these metrics are used in Whoop's sleep detection and staging algorithms. Importantly, two recent publications, published independently from Whoop, show that data on sleep stages collected from the Whoop device are highly accurate and correlate well with polysomnography (PSG), the gold-standard of sleep tracking used in clinical studies conducted in sleep clinics.
The secondary objective of the study is to determine if Defined CBD influences subjective measures of sleep physiology. We will collect this subjective data from study participants in the form of a brief five-minute survey that will be completed on their smartphone at the end of each treatment period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: