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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) endorse a desire for better sleep, (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Rest Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Rest Product Form 1 - active product 1 |
|
| Placebo Control 2 | Placebo Comparator | Rest Product Form 2 - control |
|
| Active Product 2.1 | Experimental | Rest Product Form 2 - active product 1 |
|
| Placebo Control 4.1.0 | Experimental | Rest Product 4 - control |
|
| Active Product 4.1.1 | Experimental | Rest Product 4 - active product 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radicle Rest Placebo Control Form 1 | Dietary Supplement | Participants will use their Radicle Rest Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep | Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Change in fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Participants will be stratified based on gender at birth then randomized to one of the study arms.
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Participants will be stratified based on gender at birth then randomized to one of the study arms
|
| Radicle Rest Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle Rest Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Radicle Rest Placebo Control Form 2 | Dietary Supplement | Participants will use their Radicle Rest Placebo Control Form 2 as directed for a period of 6 weeks. |
|
| Radicle Rest Active Study Product 2.1 Usage | Dietary Supplement | Participants will use their Radicle Rest Active Study Product 2.1 as directed for a period of 6 weeks. |
|
| Radicle Rest Placebo Control 4.1.0 | Dietary Supplement | Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks. |
|
| Radicle Rest Active Study Product 4.1.1 Usage | Dietary Supplement | Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks. |
|
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
| 6 weeks |
| Change in mood (emotional distress-depression) | Mean difference in emotional distress score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| Minimal clinically important difference (MCID) in sleep | Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance) | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Minimal clinically important difference (MCID) in fatigue | Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 6 weeks |
| Minimal clinically important difference (MCID) in mood (emotional distress-depression) | Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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