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| Name | Class |
|---|---|
| Reputable Health | OTHER |
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This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality. The research uses a randomized, double-blind, placebo-controlled, three-arm clinical trial design. The primary aim is to determine whether phytomelatonin improves sleep outcomes compared to placebo and whether it matches or exceeds synthetic melatonin. Participants will be randomly assigned to receive 2 mg phytomelatonin, 10 mg synthetic melatonin, or an inactive placebo. Each participant will take one capsule nightly for 28 days. Objective sleep metrics will be captured continuously using the Oura Ring wearable device. Subjective outcomes will be measured at baseline and post-intervention using validated surveys such as the Pittsburgh Sleep Quality Index and the SF-36. Weekly visual analog scales will assess morning grogginess. Safety, tolerability, and user experience differences between groups will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somato® | Experimental | Somato® Phytomelatonin 2mg |
|
| Synthetic Melatonin | Active Comparator | Synthetic Melatonin - 10mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based melatonin | Dietary Supplement | 2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28 | The PSQI is a self-administered questionnaire used to measure sleep quality and disturbances over a 1-month time interval. The questionnaire consists of 19 individual items, creating 7 component scores that are summed to yield one global score. The total score ranges from 0 to 21, where lower scores denote better sleep quality. | Baseline (Day 0) and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Objective Sleep Efficiency at Day 28 | Sleep efficiency percentage as measured continuously via the Oura Ring 3.0 wearable device. Calculated as the percentage of time in bed spent asleep. | Baseline (Day 0) and Day 28 |
| Change from Baseline Objective Total Sleep Time at Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at Day 28 | The SF-36 is a multi-purpose, short-form health survey. Scored from 0 to 100, where higher scores mean better health outcomes. | Baseline (Day 0) and Day 28 |
| Change from Baseline Morning Functioning Visual Analogue Scale (VAS) Composite Score at Day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N/A Decentralized Trial - address for CRO headquarters, not the study location | Wilmington | Delaware | 19808 | United States |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Melatonin | Dietary Supplement | 10mg Synthetic Melatonin capsule |
|
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| Placebo | Dietary Supplement | Placebo capsule |
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Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. |
| Baseline (Day 0) and Day 28 |
| Change from Baseline Objective Sleep Latency at Day 28 | The time taken to transition from full wakefulness to sleep in minutes, measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
| Change from Baseline Objective REM Sleep Duration at Day 28 | Total duration of Rapid Eye Movement (REM) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
| Change from Baseline Objective Deep Sleep Duration at Day 28 | Total duration of Deep (slow-wave) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
| Change from Baseline Objective Light Sleep Duration at Day 28 | Total duration of Light sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
| Change from Baseline Nocturnal Resting Heart Rate at Day 28 | Average overnight resting heart rate in beats per minute (bpm), measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
| Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28 | Overnight Heart Rate Variability (HRV) in milliseconds (ms) using the rMSSD (Root Mean Square of Successive Differences) method, measured continuously via the Oura Ring 3.0 wearable device. | Baseline (Day 0) and Day 28 |
Morning functioning assessed via a 6-item questionnaire utilizing a Visual Analogue Scale. Items measure dimensions such as grogginess, sleepiness, difficulty concentrating, alertness, feeling refreshed, and readiness for the day. Individual items are directionally aligned and averaged to create a composite score ranging from 1 to 10, where higher scores represent better morning functioning. |
| Baseline (Day 0) and Day 28 |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at Day 28 | The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-reported questionnaire that evaluates subjective sleep quality changes from baseline. Each component is scored on a Likert scale ranging from 0 to 3, where higher scores reflect a greater severity of sleep difficulties within that specific domain. | Baseline (Day 0) to Day 28 |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |