Sleep DisturbanceNCT07564817
A Study to Evaluate the Effects of the Speed Sleep Supplement on Sleep Quality and Quantity
A study testing Dietary Supplement: Speed Sleep in people with Sleep Disturbance, run by Bio Nature Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Dietary Supplement: Speed Sleep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2024to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep Disturbance
- Being tested
- Dietary Supplement: Speed Sleep, Placebo
- Keywords
- Sleep quality, Sleep latency, Insomnia symptoms
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Speed SleepDietary supplement
Six capsules taken once daily 30 minutes before bedtime.
PlaceboDietary supplement
Six rice flour capsules taken once daily 30 minutes before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Speed Sleep Supplement | Experimental | Participants receive Speed Sleep supplement daily for 4 weeks. Receives: Dietary Supplement: Dietary Supplement: Speed Sleep |
| Placebo | Placebo comparator | Participants receive placebo capsules daily for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Score
Assessed using Fitbit-generated sleep score reflecting overall sleep quality. Higher scores indicate better sleep quality.
Measured: Baseline and Week 4
Change in Total Sleep Time
Measured using Fitbit as total time asleep during the night.
Measured: Baseline and Week 4
Change in Time Awake During Sleep Period
Measured using Fitbit as total time awake during the sleep period.
Measured: Baseline and Week 4
Change in Number of Awakenings
Measured using Fitbit as number of awakenings during the sleep period.
Measured: Baseline and Week 4
Change in Deep Sleep Duration
Measured using Fitbit as time spent in deep sleep stages.
Measured: Baseline and Week 4
Change in REM Sleep Duration
Measured using Fitbit as time spent in REM sleep stages.
Measured: Baseline and Week 4
Change in Sleep Quality Score (SQS)
Assessed using the validated Sleep Quality Score (SQS) questionnaire. Scores reflect subjective sleep quality, with changes over time indicating improvement or decline.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Secondary outcomes (3)
Change in Sleep Latency
Assessed via questionnaire responses evaluating time required to fall asleep.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change in Self-Reported Anxiety Levels
Assessed via questionnaire responses evaluating perceived anxiety related to sleep.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change in Self-Reported Level of Relaxation
Assessed via questionnaire responses evaluating perceived relaxation before sleep.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start3 Nov 2024
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Nature Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564817
- Sponsor's protocol ID
- 20687
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of the Speed Sleep Supplement on Sleep Quality and Quantity
- ClinicalTrials.gov ID
- NCT07564817
- Acronym / sponsor ID
- 20687
- Conditions
- Sleep Disturbance
- Keywords
- Sleep quality, Sleep latency, Insomnia symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bio Nature HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speed Sleep Supplement | Experimental | Dietary Supplement: Dietary Supplement: Speed SleepParticipants receive Speed Sleep supplement daily for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants receive placebo capsules daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Aged 18-65
- Experiencing issues with sleep (falling asleep, staying asleep)
- Generally healthy
- Willing to discontinue sleep-related supplements
Key exclusion criteria (8 listed)
- Chronic medical or sleep disorders
- Use of sleep medications
- Hormone therapy or anticoagulants
- Heavy alcohol use
- Night shift workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: Speed SleepSix capsules taken once daily 30 minutes before bedtime. | Dietary supplement | Speed Sleep Supplement |
| PlaceboSix rice flour capsules taken once daily 30 minutes before bedtime. | Dietary supplement | Placebo |
Primary outcome
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.
Change in Total Sleep Time
Time frame: Baseline and Week 4
Measured using Fitbit as total time asleep during the night.
Change in Time Awake During Sleep Period
Time frame: Baseline and Week 4
Measured using Fitbit as total time awake during the sleep period.
Change in Number of Awakenings
Time frame: Baseline and Week 4
Measured using Fitbit as number of awakenings during the sleep period.
Change in Deep Sleep Duration
Time frame: Baseline and Week 4
Measured using Fitbit as time spent in deep sleep stages.
Change in REM Sleep Duration
Time frame: Baseline and Week 4
Measured using Fitbit as time spent in REM sleep stages.
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.
3 secondary outcomes
Change in Sleep Latency
Time frame: 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
Change in Self-Reported Level of Relaxation
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Speed Sleep in people with Sleep Disturbance, run by Bio Nature Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Score (time frame: Baseline and Week 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.