Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are male or female, between the ages of 35 and 65.
• People whose Body Mass Index (BMI) falls between 18.5 and 29.9 (a standard measure of body weight relative to height).
• People who are currently having trouble falling asleep, staying asleep, or waking up during the night.
• People who score 7 or lower on a specific sleep questionnaire called the RU-SATED scale.
• People who are willing to follow all study rules and procedures for the full duration of the trial.
• People who are willing to stop taking any other sleep-related supplements, herbal remedies, or over-the-counter sleep aids (such as melatonin, magnesium, or Benadryl) for the entire study period.
• People who agree to avoid alcohol within roughly 4 hours of going to bed.
• People who agree to limit caffeine to no more than 400mg per day (about 3–4 cups of coffee) and to avoid caffeine-containing products after 2:00 PM during the study.
• People who are generally healthy and do not have any chronic disease that is currently uncontrolled.
• People who currently live in the United States.

Who may not be able to join:

• People who have been diagnosed with a chronic sleep condition, such as insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, or sleep apnea.
• Women who are currently going through perimenopause or experiencing symptoms such as night sweats.
• People who have used hormone therapy (including estrogen, progesterone, or plant-based hormone alternatives) within the last 3 months.
• People who have been diagnosed with certain mental health conditions, including major depressive disorder with current active symptoms, bipolar disorder, generalised anxiety disorder with active symptoms, or PTSD with frequent nightmares.
• People who have been diagnosed with certain brain or nervous system conditions such as Parkinson's disease or Alzheimer's disease, or who have fibromyalgia that is not well managed.
• People who regularly take prescribed stimulant medications, such as Adderall, Vyvanse, Ritalin, Concerta, or Modafinil/Armodafinil.
• People who are currently taking certain antidepressants that stimulate the nervous system, including Bupropion (Wellbutrin), Fluoxetine, Venlafaxine (Effexor), or Sertraline (Zoloft).
• People who have used cannabis, THC-containing products, CBD products with measurable THC, or synthetic cannabinoids within the past 30 days.
• People whose work schedule regularly disrupts their nighttime sleep, such as those who do night shifts, third shifts, or travel very frequently.
• People who are unwilling to wear an Oura ring tracking device for the full duration of the trial, or who are unwilling to open the Oura app at least three times per week to sync data.
• People who are currently taking a prescription sleep medication.
• People who plan to start any new supplements, medications, herbal remedies, or melatonin products to help with sleep during the study period.
• People who have a known allergy or sensitivity to any ingredient in the study product (confirm with trial site for full ingredient list).
• Women who are pregnant, breastfeeding, trying to conceive, or who may become pregnant at any point during the study.
• People who have a history of substance abuse.
• Women who drink 8 or more alcoholic drinks per week, or men who drink 15 or more alcoholic drinks per week.
• People who are currently taking part in another research study, or who plan to join another research study at any point during the next 7 weeks.

Important: Always verify eligibility with the trial site directly before applying.