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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.
Placebo product
4Life Research
Sandy City, Utah, United States
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.
Time frame: 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)
Time frame: 6 weeks
Sleep Onset Latency
Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
Time frame: 6 weeks
Total Sleep Time
Total time a person spends asleep over a given night
Time frame: 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.
Time frame: 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.
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Time frame: 6 weeks