Trial · NCT05233761
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
NCT05233761, Phase 2, Completed, Defined Research; results first posted 2025-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia. Trials, record NCT05233761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05233761
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
- NCT number
- NCT05233761
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Defined Research
- Conditions
- Insomnia
- Interventions
- Defined CBD, Placebo
- First posted
- 2022-02-10
- Last updated
- 2025-09-11
- Results first posted
- 2025-09-11
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | 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. | 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. |
| Secondary | Objective Secondary Outcome Measures of Sleep Physiology | Four weeks | 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. |
| Secondary | Objective Secondary Outcome Measures of Sleep Physiology | Four weeks | 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. |
| Secondary | Subjective Secondary Outcome Measure of Sleep Physiology | 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. | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | 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. | 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). | Percentage of total sleep time | MEAN |
| SECONDARY | Objective Secondary Outcome Measures of Sleep Physiology | Four weeks | 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). | Percentage of TST | MEAN |
| SECONDARY | Objective Secondary Outcome Measures of Sleep Physiology | Four weeks | 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). | Min | MEAN |
| SECONDARY | Subjective Secondary Outcome Measure of Sleep Physiology | 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. | 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). | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | Defined CBD | 43.0 | Standard Error 0.4 | Percentage of total sleep time | |
| Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep | Placebo | 41.8 | Standard Error 0.4 | Percentage of total sleep time | |
| Objective Secondary Outcome Measures of Sleep Physiology | Defined CBD | SWS Sleep (%TST) | 19.1 | Standard Error 0.2 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Placebo | SWS Sleep (%TST) | 18.1 | Standard Error 0.2 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Defined CBD | REM Sleep (% TST) | 24.0 | Standard Error 0.3 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Placebo | REM Sleep (% TST) | 23.7 | Standard Error 0.3 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Defined CBD | Light Sleep (% TST) | 56.0 | Standard Error 0.4 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Placebo | Light Sleep (% TST) | 57.7 | Standard Error 0.4 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Defined CBD | Awake Time (% TST) | 22.4 | Standard Error 0.5 | Percentage of TST |
| Objective Secondary Outcome Measures of Sleep Physiology | Placebo | Awake Time (% TST) | 21.7 | Standard Error 0.4 | Percentage of TST |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period A | STARTED | Group 1 (A to B: A = Placebo; B = Defined CBD) | 63 | |
| Treatment Period A | STARTED | Group 2 (B to A: B = Defined CBD; A = Placebo) | 62 | |
| Treatment Period A | COMPLETED | Group 1 (A to B: A = Placebo; B = Defined CBD) | 37 | |
| Treatment Period A | COMPLETED | Group 2 (B to A: B = Defined CBD; A = Placebo) | 25 | |
| Treatment Period A | NOT COMPLETED | Group 1 (A to B: A = Placebo; B = Defined CBD) | 26 | |
| Treatment Period A | NOT COMPLETED | Group 2 (B to A: B = Defined CBD; A = Placebo) | 37 | |
| Treatment Period B | STARTED | Group 1 (A to B: A = Placebo; B = Defined CBD) | 37 | |
| Treatment Period B | STARTED | Group 2 (B to A: B = Defined CBD; A = Placebo) | 25 | |
| Treatment Period B | COMPLETED | Group 1 (A to B: A = Placebo; B = Defined CBD) | 37 | |
| Treatment Period B | COMPLETED | Group 2 (B to A: B = Defined CBD; A = Placebo) | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Defined CBD | 0 | 99 |
| Total, all-cause mortality | Placebo | 0 | 88 |
| Total, other adverse events | Defined CBD | 0 | 99 |
| Total, other adverse events | Placebo | 0 | 88 |
| Total, serious adverse events | Defined CBD | 0 | 99 |
| Total, serious adverse events | Placebo | 0 | 88 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39167421 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Defined CBD vs Placebo: deaths from any cause | Trial comparisons |
| Defined CBD vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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