Sleep Supplements for Sleep
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effects of four different nutritional supplements on sleep in healthy adults. Participants will be randomly assigned to one of five groups, including a placebo group, to compare results over a 12-week period. This study suits individuals who have trouble sleeping but lack diagnosed sleep disorders and can maintain their usual diets and routines. As a Phase 1 trial, the research focuses on understanding how these supplements work in people, offering participants the unique opportunity to be among the first to receive this treatment.
Will I have to stop taking my current medications?
Yes, if you are currently taking prescribed sleep medications or medications that affect sleep, you will need to stop as they are not allowed in this study. Additionally, you must not have taken these medications in the past 4 weeks before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that melatonin, the main ingredient in Sleep Supplements 1, 2, 3, and 4, is generally safe for short-term use. Studies have found that melatonin usually doesn't lead to dependency, unlike some other sleep medications. However, limited information exists on its long-term safety. Some research hints at a possible connection between long-term melatonin use and heart problems, but this doesn't confirm causation. Most people experience few side effects, similar to those taking a placebo. Overall, these supplements appear well-tolerated for short-term use, but the long-term effects remain under study.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these sleep supplements because they offer potential new ways to tackle sleep issues. Unlike typical sleep aids that often rely on sedative properties, these supplements might include unique natural ingredients or innovative formulations that work differently to promote restful sleep. Such differences could lead to fewer side effects or dependencies, setting them apart from standard medications like melatonin or prescription sleep aids. By targeting sleep quality in various ways, these supplements could potentially provide faster and more effective relief for those struggling with sleep problems.
What evidence suggests that this trial's treatments could be effective for sleep?
This trial will evaluate the effectiveness of different sleep supplements. Research has shown that Sleep Supplement 1, which participants in this trial may receive, can improve sleep by helping individuals fall asleep more quickly and wake up less often. Sleep Supplement 2, another option in this trial, also demonstrated benefits, with melatonin and other ingredients enhancing sleep and reducing the time to fall asleep. Sleep Supplement 3, also under study, has been linked to better sleep and fewer disturbances. Studies on Sleep Supplement 4, another treatment arm, indicate it helps people fall asleep faster and improves overall sleep, with melatonin playing a key role. Overall, these supplements have shown positive effects on sleep in various studies.678910
Are You a Good Fit for This Trial?
Healthy U.S. adults aged 18-65 with mild sleep issues can join this study. They must not have a history of substance abuse, high caffeine intake, or be on certain medications that affect sleep. Pregnant women and those not using effective contraception are excluded, as well as anyone with irregular work hours affecting sleep.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of four nutritional supplements or a placebo over a 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sleep Supplements
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pharmavite LLC
Lead Sponsor