Sleep Health, Sleep Quality
Conditions
Keywords
Sleep Health, Sleep Quality, Melatonin, Lavender essential oil, GABA
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSleep Supplement
Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.
DIETARY_SUPPLEMENTPlacebo
Placebo product
Sponsors
4Life Research, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-smokers * Judged by the Investigator to be in general good health on the basis of medical history * Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study * Insomnia Severity Index score of ≥ 8 * Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Exclusion criteria
* Pregnant and/or lactating women * Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium * Prescription sedative or psychoactive (including anti-depressant) medication use * Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history * A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer) * Routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 PM for the duration of the study * Illicit drug use * Use of prescription stimulants (modafinil, dextroamphetamine, etc.) * Use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ACE inhibitors, angiotensin II-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants) * Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit * Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months * Unwilling to consume or unable to swallow capsules/tablets * Previous exposure to this product in earlier testing phases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Saliva Melatonin level changes | 6 weeks | 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. |
| Insomnia Severity Index Score | 6 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | 6 weeks | Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out. |
| Total Sleep Time | 6 weeks | Total time a person spends asleep over a given night |
| Sleep Efficiency | 6 weeks | 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. |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Score | 6 weeks | 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. |
Countries
United States
Outcome results
None listed