Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Change from baseline sleep quality index
Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline sleep duration and quality from diary
Change from baseline with Daily Sleep Diary
Time frame: Baseline and Daily for 28 days
Change from baseline perceived stress scale
Change from baseline with validated perceived stress questionnaire
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline Insomnia severity index
Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia)
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)
Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in mood
Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in skin attributes
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Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc)
Time frame: Baseline, Day 7, and Day 28