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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defined CBD | Experimental | Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. |
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| Placebo | Placebo Comparator | The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defined CBD | Drug | 300 mg CBD and 8 mg Terpenes administered as two small capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | The primary endpoint is the percentage of time spent in slow wave (Deep) and REM sleep as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. | Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Secondary Outcome Measures of Sleep Physiology | The percentage of time spent in each sleep stage (SWS, REM, light and awake) relative to total sleep time as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. | Four weeks |
| Objective Secondary Outcome Measures of Sleep Physiology |
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Inclusion Criteria:
Has provided a signed and dated informed consent form.
Presence of chronic insomnia defined as self-reported difficulty initiating (latency to persistent sleep >30 min) and/or maintaining sleep (>30 mins awake during the middle of the night, or waking >30 mins before desired waking time on three or more nights per week) for at least 3 months.
Insomnia Severity Index score >15.
Male or female aged 25-70 years.
Is willing to comply with all study procedures throughout the entire study, including:
On the nights in which the participant takes the treatment, is willing to abstain from excessive alcohol intake (>two drinks/day).
On the nights in which the participant takes the treatment, is willing to refrain from drinking alcohol two hours before bedtime.
Female subjects who:
Self-reported bedtime between 9 pm and midnight on four-seven nights per week.
Owns a smartphone.
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Muchowski, Ph.D. | Defined Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Defined Research | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39167421 | Derived | Wang M, Faust M, Abbott S, Patel V, Chang E, Clark JI, Stella N, Muchowski PJ. Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study. J Clin Sleep Med. 2025 Jan 1;21(1):69-80. doi: 10.5664/jcsm.11324. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (A to B: A = Placebo; B = Defined CBD) | The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules. Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. |
| FG001 | Group 2 (B to A: B = Defined CBD; A = Placebo) | Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period A |
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| Treatment Period B |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (A to B: A = Placebo; B = Defined CBD) | The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules. Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | The primary endpoint is the percentage of time spent in slow wave (Deep) and REM sleep as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. | Data from six participants [four participants from Group 1 (A/B) and two participants from Group 2 (B/A)] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection). | Posted | Mean | Standard Error | Percentage of total sleep time | Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period. |
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Adverse events were collected on a daily basis by a medical monitor throughout the 12 week duration of the study.
The definitions of adverse events and/or serious adverse events that were used to collect adverse event information were identical to those described by clinical trials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Defined CBD | Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules. |
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First, the study was not conducted in a sleep clinic using polysomnography. Second, the wrist-worn sleep-tracking device used in the current study does not measure sleep latency and may not be sufficiently accurate to report sleep staging. Third, the unexpected high dropout rate in the study limited its statistical power, especially with respect to subjective outcome measures of sleep.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Muchowski | Defined Research Institute | 415-413-8666 | paul.muchowski@definedresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2022 | Jul 1, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo |
| Drug |
Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes. |
|
The absolute time spent in each sleep stage (SWS, REM, light and awake) as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. |
| Four weeks |
| Subjective Secondary Outcome Measure of Sleep Physiology | A modified version of a clinically validated questionnaire/survey entitled the patient's global impression (PGI) was used to assess subjective perceptions of sleep by the study participants after each four-week treatment period. The modified PGI is a five-item, subjective, participant self-report that assesses treatment benefit to sleep quality (Item 1), sleep induction (Item 2), sleep duration (Item 3), sleep depth (Item 4) and treatment effect on the presence of vivid dreams (item 5). Each item in our modified PGI was presented as a survey that consisted of a ten-point categorical scale, with scores between 6-10 representing a treatment benefit/advantage, a score of 5 representing no effect of treatment, and a score of 1-4 representing a treatment worsening/disadvantage. | Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period. |
| Protocol Violation |
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| NOT COMPLETED |
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| BG001 | Group 2 (B to A: B = Defined CBD; A = Placebo) | Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules look and smell identical to the Defined CBD capsules. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Defined CBD: 300 mg CBD and 8 mg Terpenes administered as two small capsules.
| OG001 | Placebo | The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules. Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes. |
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|
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| Secondary | Objective Secondary Outcome Measures of Sleep Physiology | The percentage of time spent in each sleep stage (SWS, REM, light and awake) relative to total sleep time as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. | Data from six participants [four participants from Group 1 (A/B) and two participants from Group 2 (B/A)] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection). | Posted | Mean | Standard Error | Percentage of TST | Four weeks |
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|
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| Secondary | Objective Secondary Outcome Measures of Sleep Physiology | The absolute time spent in each sleep stage (SWS, REM, light and awake) as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop. | Data from six participants [four participants from Group 1 (A/B) and two participants from Group 2 (B/A)] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection). | Posted | Mean | Standard Error | Min | Four weeks |
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| Secondary | Subjective Secondary Outcome Measure of Sleep Physiology | A modified version of a clinically validated questionnaire/survey entitled the patient's global impression (PGI) was used to assess subjective perceptions of sleep by the study participants after each four-week treatment period. The modified PGI is a five-item, subjective, participant self-report that assesses treatment benefit to sleep quality (Item 1), sleep induction (Item 2), sleep duration (Item 3), sleep depth (Item 4) and treatment effect on the presence of vivid dreams (item 5). Each item in our modified PGI was presented as a survey that consisted of a ten-point categorical scale, with scores between 6-10 representing a treatment benefit/advantage, a score of 5 representing no effect of treatment, and a score of 1-4 representing a treatment worsening/disadvantage. | Data from six participants [four participants from Group 1 (A/B) and two participants from Group 2 (B/A)] were excluded from the final data analysis due to protocol deviations (e.g. due to a lack of reporting whether or not they took the study treatment, and/or insufficient sleep data collection). | Posted | Mean | Standard Error | Units on a scale | Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period. |
|
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|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Placebo | The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules. Placebo: Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes. | 0 | 88 | 0 | 88 | 0 | 88 |
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| D001523 |
| Mental Disorders |
| Light Sleep (% TST) |
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| Awake Time (% TST) |
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| The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.52 | Mean Difference (Final Values) | 0.3 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -.6 | 1.2 | Superiority | The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.0040 | Mean Difference (Final Values) | -1.7 | Standard Error of the Mean | 0.6 | 2-Sided | 95 | -2.8 | -0.5 | Superiority | The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.24 | Mean Difference (Final Values) | 0.7 | Standard Error of the Mean | 0.6 | 2-Sided | 95 | -.5 | 2.0 | Superiority | The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| REM Sleep (min) |
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| Light Sleep (min) |
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| Awake Time (min) |
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| Total Sleep Time (min) |
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| The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.0126 | Mean Difference (Final Values) | 3.3 | Standard Error of the Mean | 1.3 | 2-Sided | 95 | 0.7 | 5.9 | Superiority | The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.51 | Mean Difference (Final Values) | 1.3 | Standard Error of the Mean | 2.0 | 2-Sided | 95 | -2.7 | 5.3 | Superiority | The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.0574 | Mean Difference (Final Values) | -6.8 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -13.7 | 0.2 | Superiority | The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.3 | Mean Difference (Final Values) | 2.2 | Standard Error of the Mean | 2.4 | 2-Sided | 95 | -2.4 | 6.9 | Superiority | The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.14 | Mean Difference (Final Values) | -6.9 | Standard Error of the Mean | 4.7 | 2-Sided | 95 | -16.1 | 2.4 | Superiority | The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method. |
| Sleep Duration |
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| Sleep Depth |
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| Vivid Dreams |
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| The null hypothesis was that there was no difference in the perception of "sleep induction" in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.32 | Mean Difference (Final Values) | 0.6 | Standard Error of the Mean | 0.6 | 2-Sided | 95 | -0.6 | 1.7 | Superiority | The mean nightly difference in the perception of "sleep induction" in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in the perception of "sleep duration" in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.20 | Mean Difference (Final Values) | 0.7 | Standard Error of the Mean | 0.6 | 2-Sided | 95 | -0.4 | 1.9 | Superiority | The mean nightly difference in the perception of "sleep duration" in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in the perception of "sleep depth" in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.45 | Mean Difference (Final Values) | 0.5 | Standard Error of the Mean | 0.6 | 2-Sided | 95 | -0.7 | 1.6 | Superiority | The mean nightly difference in the perception of "sleep depth" in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method. |
| The null hypothesis was that there was no difference in the perception of "vivid dreams" in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups. | t-test, 2 sided | 0.4 | Mean Difference (Final Values) | 0.6 | Standard Error of the Mean | 0.7 | 2-Sided | 95 | -0.8 | 1.9 | Superiority | The mean nightly difference in the perception of "vivid dreams" in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method. |