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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clevr Blends Arm | Experimental | Weeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevr Sleeptime | Other | Participants will trial Clevr Blends Sleeptime during weeks 1-4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4] | All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night. | 4 weeks |
| Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4] | Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating and maintaining sleep, difficulty waking, and sleep satisfaction. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). | 4 weeks |
| Changes in self-reported energy levels. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score. | 12 weeks |
| Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in self-reported caffeine side effects, | Measured via study-specific questionnaires reviewing jitters, caffeine crashes, anxiety, negative moods and dependency. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| Clevr Matcha | Other | Participants will trial Clevr Matcha during weeks 5-8. |
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| Clevr Chai | Other | Participants will trial Clevr Chai during weeks 9-12. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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