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Dietary Supplement

Health and Wellness Products for Sleep Disorders

N/A

Waitlist Available

Led By Emily K. Pauli, PharmD

Research Sponsored by Radicle Science

Eligibility Criteria Checklist

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

Must have

Endorses better sleep as a primary desire

Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial tested how using health/wellness products affects people's sleep and other health outcomes. It was designed to be fair and unbiased.

Who is the study for?

Adults over 21 in the U.S. who want to improve their sleep or reduce reliance on sleep medications can join this study. They must be willing to take an unknown product (active or placebo) and have internet access. Excluded are pregnant/breastfeeding individuals, those with liver/kidney disease, heavy drinkers, people taking certain drugs, and anyone with severe heart conditions.Check my eligibility

What is being tested?

The trial is testing various health and wellness products against placebos to see if they help with sleep issues. Participants won't know if they're getting a real product or a placebo until the end of the study, which is designed to measure how these products affect sleep quality.See study design

What are the potential side effects?

Since specific side effects aren't listed for the active products being tested, potential side effects typically range from none (placebo) to mild digestive discomfort, allergic reactions, headaches or dizziness depending on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I want to improve my sleep quality.

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I am 21 years old or older.

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I am willing to take part in the study without knowing if I'm receiving the actual treatment or a placebo.

Select...

I want to improve my sleep or reduce my use of sleep medications.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in sleep disturbance

Secondary outcome measures

Change in anxiety

Change in cognitive function

Change in fatigue

+3 more

Trial Design

12Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Product 4.3Experimental Treatment1 Intervention

Rest Product Form 4 - active product 3

Group II: Active Product 4.2Experimental Treatment1 Intervention

Rest Product Form 4 - active product 2

Group III: Active Product 4.1Experimental Treatment1 Intervention

Rest Product Form 4 - active product 1

Group IV: Active Product 3.1Experimental Treatment1 Intervention

Rest Product Form 3 - active product 1

Group V: Active Product 2.2Experimental Treatment1 Intervention

Rest Product Form 2 - active product 2

Group VI: Active Product 2.1Experimental Treatment1 Intervention

Rest Product Form 2 - active product 1

Group VII: Active Product 1.2Experimental Treatment1 Intervention

Rest Product Form 1 - active product 2

Group VIII: Active Product 1.1Experimental Treatment1 Intervention

Rest Product Form 1 - active product 1

Group IX: Placebo Control 4Placebo Group1 Intervention

Rest Product Form 4 - control

Group X: Placebo Control 1Placebo Group1 Intervention

Rest Product Form 1 - control

Group XI: Placebo Control 3Placebo Group1 Intervention

Rest Product Form 3 - control

Group XII: Placebo Control 2Placebo Group1 Intervention

Rest Product Form 2 - control

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Radicle ScienceLead Sponsor

17 Previous Clinical Trials

32,441 Total Patients Enrolled

4 Trials studying Sleep

7,123 Patients Enrolled for Sleep

Emily K. Pauli, PharmDPrincipal InvestigatorRadicle Science, Inc

13 Previous Clinical Trials

24,914 Total Patients Enrolled

3 Trials studying Sleep

5,373 Patients Enrolled for Sleep

Media Library

Rest Study Active Product 1.1 Usage (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05657808 — N/A

Sleep Research Study Groups: Placebo Control 4, Placebo Control 1, Placebo Control 3, Active Product 3.1, Active Product 2.1, Active Product 4.2, Active Product 4.1, Active Product 1.1, Active Product 2.2, Active Product 1.2, Placebo Control 2, Active Product 4.3

Sleep Clinical Trial 2023: Rest Study Active Product 1.1 Usage Highlights & Side Effects. Trial Name: NCT05657808 — N/A

Rest Study Active Product 1.1 Usage (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657808 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric recruitment expected for this medical experiment?

"This clinical trial requires that potential patients are aged between 21 and 105. For those under 18 years of age, there are 66 trials available whereas 202 have been created for seniors over 65."

Answered by AI

What are the qualifications to participate in this research project?

"This research aims to recruit three hundred individuals between 21 and 105 years old. Furthermore, these applicants should be of any ethnicity or gender identity, looking for ways to better their sleep without relying on medication. They must also have residence in the USA and express a desire to take part in this study while not knowing which product they are consuming until its conclusion."

Answered by AI

Are there any openings for volunteers in this trial?

"The listing for this trial on clinicaltrials.gov suggests that patient recruitment has already been completed - the posting was initially made public on September 1st 2023 and modified most recently on December 12th 2022. Fortunately, there are 307 active trials recruiting patients currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes

2023. "Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05657808.