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The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 before Cross Over | Experimental | Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week. |
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| Arm 2 after Cross Over | Experimental | In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Supplement | Dietary Supplement | Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium. |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva Melatonin level changes | Samples taken before bedtime at night and 2 hours after wakeup the next morning. A total of 8 samples were taken for each subject: (2) right after first washout, (2) right after Arm 1, (2) right after the second washout, (2) right after Arm 2. | 6 weeks |
| Insomnia Severity Index Score | A scale used to measure the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency | Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out. | 6 weeks |
| Total Sleep Time | Total time a person spends asleep over a given night |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4Life Research | Sandy City | Utah | 84070 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo | Dietary Supplement | Placebo product |
|
| 6 weeks |
| Sleep Efficiency | Sleep efficiency is typically referring to the percentage of time a person spends asleep at night. To calculate this, you take a ratio of the total amount of time a person was asleep on a given night divided by the total amount of time they spent in bed, then multiply that by 100 to create a percentage. | 6 weeks |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Score | A 10-item, subjective, self-report measure, the LSEQ was designed to assess changes in sleep quality over the course of a psychopharmacological treatment intervention. The scale evaluates four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. Total LSEQ Score ranges from 0 to 100, with 100 being the worst sleep quality and health overall. | 6 weeks |
| D001523 |
| Mental Disorders |