SleepNCT06146517
A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
A study testing Clevr Sleeptime, Clevr Matcha and Clevr Chai in people with Sleep and Mood, run by Clevr Blends at 1 site in United States.
Trial summary
This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Read more about this study
- Who is it for?
- Ages 28 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Mood, Caffeine Withdrawal
- What is being tested?
- Clevr Sleeptime, Clevr Matcha and Clevr Chai
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 22 Jan 2024
- 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 28 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female.
- Age 28-42.
- Generally healthy without any uncontrolled or chronic disease.
- Must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily.
- Looking for healthier alternatives to caffeine.
- Currently owns a wearable sleep tracking device (e.g. Fitbit, Whoop, Oura etc) and has been wearing consistently for 4 weeks.
- Resident of the USA.
Who cannot join
- Allergies to any of the ingredients in the three products.
- Anyone with a formal diagnosis of insomnia.
- Any pre-existing or chronic conditions that would prevent participants from adhering to the protocol.
- Women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial.
- Unwilling to follow the protocol.
- Participants that consume more than two caffeinated drinks daily.
- Participants that have little to no caffeine daily, equivalent to less than 1 cup of coffee daily.
- Is not a resident of the USA.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.
- Conditions
- Sleep, Mood, Caffeine Withdrawal, Anxiety, Productivity
- Being tested
- Clevr Sleeptime, Clevr Matcha, Clevr Chai
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevr SleeptimeOther
Participants will trial Clevr Blends Sleeptime during weeks 1-4.
Clevr MatchaOther
Participants will trial Clevr Matcha during weeks 5-8.
Clevr ChaiOther
Participants will trial Clevr Chai during weeks 9-12.
| Study group | Role | What they receive |
|---|---|---|
| Clevr Blends Arm | Experimental | Weeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided.
Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided.
Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Receives: Other: Clevr Sleeptime; Other: Clevr Matcha; Other: Clevr Chai |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4]
All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night.
Measured: 4 weeks
Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4]
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating and maintaining sleep, difficulty waking, and sleep satisfaction. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always").
Measured: 4 weeks
Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Measured: 12 weeks
Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Measured: 12 weeks
Secondary outcomes (1)
Changes in self-reported caffeine side effects,
Measured via study-specific questionnaires reviewing jitters, caffeine crashes, anxiety, negative moods and dependency. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start31 Aug 2023
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clevr Blends
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146517
- Sponsor's protocol ID
- 20341
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
- ClinicalTrials.gov ID
- NCT06146517
- Acronym / sponsor ID
- 20341
- Conditions
- Sleep, Mood, Caffeine Withdrawal, Anxiety, Productivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Clevr BlendsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 24 Nov 2023 (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 is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clevr Blends Arm | Experimental | Other: Clevr Sleeptime, Other: Clevr Matcha, Other: Clevr ChaiWeeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. |
Who may qualify
- Ages
- 28 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female.
- Age 28-42.
- Generally healthy without any uncontrolled or chronic disease.
- Must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily.
- Looking for healthier alternatives to caffeine.
Key exclusion criteria (8 listed)
- Allergies to any of the ingredients in the three products.
- Anyone with a formal diagnosis of insomnia.
- Any pre-existing or chronic conditions that would prevent participants from adhering to the protocol.
- Women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial.
- Unwilling to follow the protocol.
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 |
|---|---|---|
| Clevr SleeptimeParticipants will trial Clevr Blends Sleeptime during weeks 1-4. | Other | Clevr Blends Arm |
| Clevr MatchaParticipants will trial Clevr Matcha during weeks 5-8. | Other | Clevr Blends Arm |
| Clevr ChaiParticipants will trial Clevr Chai during weeks 9-12. | Other | Clevr Blends Arm |
Primary outcome
Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4]
Time frame: 4 weeks
All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night.
Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4]
Time frame: 4 weeks
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating and maintaining sleep, difficulty waking, and sleep satisfaction. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always").
Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
1 secondary outcome
Changes in self-reported caffeine side effects,
Time frame: 12 weeks
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 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
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 Clevr Sleeptime, Clevr Matcha and Clevr Chai in people with Sleep and Mood, run by Clevr Blends 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 22 Aug 2024. 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. 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 quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4] (time frame: 4 weeks). The study lists 4 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 22 Aug 2024.