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Dietary Supplement

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
Awards & highlights

Study 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.

Eligible Conditions
  • Sleep Quality
  • Sleep Hygiene

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index Score
Saliva Melatonin level changes
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

4Life Research, LLCLead Sponsor
5 Previous Clinical Trials
180 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
2021. "Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368909.
~9 spots leftby Apr 2025
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