- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07564817
A Study to Evaluate the Effects of the Speed Sleep Supplement on Sleep Quality and Quantity
April 27, 2026 updated by: Bio Nature Health
This study evaluates the effects of the Speed Sleep supplement on sleep quality and quantity in adults aged 18-65 years.
Participants will be randomized to receive either the supplement or placebo for 4 weeks, with outcomes assessed using Fitbit sleep tracking data and questionnaires.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male or female
- Aged 18-65
- Experiencing issues with sleep (falling asleep, staying asleep)
- Generally healthy
- Willing to discontinue sleep-related supplements
- Maintain consistent sleep patterns
- Resides in the United States
Exclusion Criteria:
- Chronic medical or sleep disorders
- Use of sleep medications
- Hormone therapy or anticoagulants
- Heavy alcohol use
- Night shift workers
- Pregnancy or breastfeeding
- Smoking or substance abuse
- Allergies to ingredients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Speed Sleep Supplement
Participants receive Speed Sleep supplement daily for 4 weeks.
|
Six capsules taken once daily 30 minutes before bedtime.
|
|
Placebo Comparator: Placebo
Participants receive placebo capsules daily for 4 weeks.
|
Six rice flour capsules taken once daily 30 minutes before bedtime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Score
Time Frame: Baseline and Week 4
|
Assessed using Fitbit-generated sleep score reflecting overall sleep quality.
Higher scores indicate better sleep quality.
|
Baseline and Week 4
|
|
Change in Total Sleep Time
Time Frame: Baseline and Week 4
|
Measured using Fitbit as total time asleep during the night.
|
Baseline and Week 4
|
|
Change in Time Awake During Sleep Period
Time Frame: Baseline and Week 4
|
Measured using Fitbit as total time awake during the sleep period.
|
Baseline and Week 4
|
|
Change in Number of Awakenings
Time Frame: Baseline and Week 4
|
Measured using Fitbit as number of awakenings during the sleep period.
|
Baseline and Week 4
|
|
Change in Deep Sleep Duration
Time Frame: Baseline and Week 4
|
Measured using Fitbit as time spent in deep sleep stages.
|
Baseline and Week 4
|
|
Change in REM Sleep Duration
Time Frame: Baseline and Week 4
|
Measured using Fitbit as time spent in REM sleep stages.
|
Baseline and Week 4
|
|
Change in Sleep Quality Score (SQS)
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4
|
Assessed using the validated Sleep Quality Score (SQS) questionnaire.
Scores reflect subjective sleep quality, with changes over time indicating improvement or decline.
|
Baseline, Week 1, Week 2, Week 3, Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Latency
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4
|
Assessed via questionnaire responses evaluating time required to fall asleep.
|
Baseline, Week 1, Week 2, Week 3, Week 4
|
|
Change in Self-Reported Anxiety Levels
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4
|
Assessed via questionnaire responses evaluating perceived anxiety related to sleep.
|
Baseline, Week 1, Week 2, Week 3, Week 4
|
|
Change in Self-Reported Level of Relaxation
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4
|
Assessed via questionnaire responses evaluating perceived relaxation before sleep.
|
Baseline, Week 1, Week 2, Week 3, Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2024
Primary Completion (Actual)
January 13, 2025
Study Completion (Actual)
January 13, 2025
Study Registration Dates
First Submitted
April 27, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20687
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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