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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This study evaluates the effects of the Speed Sleep supplement on sleep quality and quantity in adults aged 18-65 years. Participants will be randomized to receive either the supplement or placebo for 4 weeks, with outcomes assessed using Fitbit sleep tracking data and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speed Sleep Supplement | Experimental | Participants receive Speed Sleep supplement daily for 4 weeks. |
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| Placebo | Placebo Comparator | Participants receive placebo capsules daily for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Speed Sleep | Dietary Supplement | Six capsules taken once daily 30 minutes before bedtime. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Score | Assessed using Fitbit-generated sleep score reflecting overall sleep quality. Higher scores indicate better sleep quality. | Baseline and Week 4 |
| Change in Total Sleep Time | Measured using Fitbit as total time asleep during the night. | Baseline and Week 4 |
| Change in Time Awake During Sleep Period | Measured using Fitbit as total time awake during the sleep period. | Baseline and Week 4 |
| Change in Number of Awakenings | Measured using Fitbit as number of awakenings during the sleep period. | Baseline and Week 4 |
| Change in Deep Sleep Duration | Measured using Fitbit as time spent in deep sleep stages. | Baseline and Week 4 |
| Change in REM Sleep Duration | Measured using Fitbit as time spent in REM sleep stages. | Baseline and Week 4 |
| Change in Sleep Quality Score (SQS) | Assessed using the validated Sleep Quality Score (SQS) questionnaire. Scores reflect subjective sleep quality, with changes over time indicating improvement or decline. | Baseline, Week 1, Week 2, Week 3, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Latency | Assessed via questionnaire responses evaluating time required to fall asleep. | Baseline, Week 1, Week 2, Week 3, Week 4 |
| Change in Self-Reported Anxiety Levels | Assessed via questionnaire responses evaluating perceived anxiety related to sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Placebo | Dietary Supplement | Six rice flour capsules taken once daily 30 minutes before bedtime. |
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| Baseline, Week 1, Week 2, Week 3, Week 4 |
| Change in Self-Reported Level of Relaxation | Assessed via questionnaire responses evaluating perceived relaxation before sleep. | Baseline, Week 1, Week 2, Week 3, Week 4 |
| D020920 | Dyssomnias |