SleepNCT05521243
An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
A study testing Beam Organics Dream Powder and Beam Organics Dream Powder Extra Strength in people with Sleep and Sleep Disturbance, run by Beam at 1 site in United States.
Trial summary
This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period. Read more about this study
- Who is it for?
- Ages 24 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Disturbance, Sleep Hygiene
- What is being tested?
- Beam Organics Dream Powder and Beam Organics Dream Powder Extra Strength
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 30 Sep 2022
- 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 24 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, "FitBit", "Whoop", etc.) Must be willing to discontinue any supplements meant to assist with sleep.
Who cannot join
- Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions
Trial locations and contacts
1 site in 1 country.
About this study
This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene
- Being tested
- Beam Organics Dream Powder, Beam Organics Dream Powder Extra Strength, Placebo
- Keywords
- Sleep, Sleep Disturbance, Sleep Quality, Sleep Quantity
- Medical subject headings
- Parasomnias, Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beam Organics Dream PowderDietary supplement
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
Beam Organics Dream Powder Extra StrengthDietary supplement
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
PlaceboDietary supplement
The main ingredients in the placebo are:
Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Dream Powder | Experimental | Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks. Receives: Dietary Supplement: Beam Organics Dream Powder; Dietary Supplement: Placebo |
| Placebo + Dream Powder Extra Strength | Experimental | Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks. Receives: Dietary Supplement: Beam Organics Dream Powder Extra Strength; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Changes in Sleep Quality as reported by questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Measured: 6 Weeks
Perceived Changes in Sleep Quantity as reported by questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Measured: 6 weeks
Perceived Changes in Sleep Habits as reported by Questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Measured: 6 weeks
Participant Perceptions of Sleep
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Measured: 6 weeks
Secondary outcomes (1)
Examine changes in device measured sleep across the six week trial.
Sleep will be measured with fitness trackers to provide an objective outcome measure of sleep across the six week trial. Both sleep time and sleep quality will be examined. Participants will report their sleep data from the previous week at Baseline, Week 2, Week 4, and Week 6.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start9 May 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beam
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Christopher Hill, PhD, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521243
- Sponsor's protocol ID
- 20241
- Status last verified
- Nov 2022
- First submitted
- 24 Aug 2022
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
- ClinicalTrials.gov ID
- NCT05521243
- Acronym / sponsor ID
- 20241
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene
- Keywords
- Sleep, Sleep Disturbance, Sleep Quality, Sleep Quantity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BeamIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 30 Aug 2022 (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 double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Dream Powder | Experimental | Dietary Supplement: Beam Organics Dream Powder, Dietary Supplement: PlaceboParticipants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks. |
| Placebo + Dream Powder Extra Strength | Experimental | Dietary Supplement: Beam Organics Dream Powder Extra Strength, Dietary Supplement: PlaceboParticipants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks. |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, "FitBit", "Whoop", etc.) Must be willing to discontinue any supplements meant to assist with sleep.
Key exclusion criteria (1 listed)
- Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions
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 |
|---|---|---|
| Beam Organics Dream PowderThe Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern | Dietary supplement | Placebo + Dream Powder |
| Beam Organics Dream Powder Extra StrengthThe Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern | Dietary supplement | Placebo + Dream Powder Extra Strength |
| PlaceboThe main ingredients in the placebo are: Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor | Dietary supplement | Placebo + Dream Powder, Placebo + Dream Powder Extra Strength |
Primary outcome
Perceived Changes in Sleep Quality as reported by questionnaires
Time frame: 6 Weeks
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Perceived Changes in Sleep Quantity as reported by questionnaires
Time frame: 6 weeks
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Perceived Changes in Sleep Habits as reported by Questionnaires
Time frame: 6 weeks
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Participant Perceptions of Sleep
Time frame: 6 weeks
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
1 secondary outcome
Examine changes in device measured sleep across the six week trial.
Time frame: 6 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 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Hill, PhD principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beam Organics Dream Powder and Beam Organics Dream Powder Extra Strength in people with Sleep and Sleep Disturbance, run by Beam 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 1 inclusion and 1 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 8 Nov 2022. 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?
Perceived Changes in Sleep Quality as reported by questionnaires (time frame: 6 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 8 Nov 2022.