Arm 1 before Cross Over for Sleep Quality

N/A

Waitlist Available

Research Sponsored by 4Life Research, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial is testing a special oral supplement to see if it can help people with sleep problems sleep better. Melatonin is considered a nutritional supplement and not regulated as a prescription medication in most countries; although safety data over extended periods are not available, studies suggest that it is relatively safe for most people.

Eligible Conditions

Sleep Quality
Sleep Hygiene

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index Score

Saliva Melatonin level changes

Secondary study objectives

Leeds Sleep Evaluation Questionnaire (LSEQ) Score

Sleep Efficiency

Sleep Onset Latency

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 after Cross OverExperimental Treatment2 Interventions

In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week.

Group II: Arm 1 before Cross OverExperimental Treatment2 Interventions

Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Supplement

2021

N/A

~30

Placebo

1995

Completed Phase 3

~2670