SleepNCT07298161
Evaluating SleepWhale Drops for Rest & Resilience
A study testing SleepWhale Natural Sleep Drops in people with Sleep, run by Efforia, Inc at 1 site in United States.
Trial summary
30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)-formulated to support deeper sleep and better days. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- SleepWhale Natural Sleep Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
- Individuals with Allergies to supplement ingredients
- Individuals on sleep Medication
- Individuals with Gastrointestinal Issues
- Individuals with Skin Conditions
- Individuals Prone to Headaches
- Individuals with Mental Health Conditions
Show all 10Show fewer
- Pregnant or Breastfeeding Individuals
- Athletes and Competitive Participants
- Individuals with Dependency Issues
- Individuals with Dizziness or Fatigue Issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)-formulated to support deeper sleep and better days.
Read the detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the efficacy of SleepWhale Natural Sleep Drops (Extra Strength), a non-melatonin sleep aid composed of adaptogens and botanicals, in improving sleep quality and daytime well-being. Recognizing the pervasive issues of sleep disturbances including racing thoughts, restless nights, and sluggish mornings, and the growing interest in natural remedies that provide support without the risk of grogginess or dependency, this study aims to provide empirical evidence on the benefits of SleepWhale.
Participants in this trial will incorporate SleepWhale Drops into their nightly routine for a duration of 30 days. Throughout this period, participants are required to complete weekly check-ins utilizing scientifically validated self-report tools. This approach is chosen to emphasize the subjective experience of sleep quality and daytime functioning over metrics that might be collected by sleep trackers or wearable devices, which, while useful, can sometimes lack accuracy and fail to capture the entirety of an individual's sleep experience.
The primary objective of this study is to assess the impact of regular nightly use of SleepWhale Natural Sleep Drops on several key outcomes, including self-reported sleep quality, incidences of sleep disruption, daytime performance, and overall resilience. By focusing on these areas, the study aims to gather meaningful data that reflects the real-world effectiveness of SleepWhale Drops in supporting restful sleep and enhancing daytime productivity and well-being.
Ultimately, by participating in this trial, individuals will not only contribute to their personal health and well-being but also to the larger body of research aimed at validating the effectiveness of SleepWhale Natural Sleep Drops. This study stands as a critical step towards separating trend from truth, offering participants and the wider community real outcomes and insights into the potential of SleepWhale as a natural solution for better sleep and brighter days.
- Conditions
- Sleep
- Being tested
- SleepWhale Natural Sleep Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepWhale Natural Sleep DropsDietary supplement
Broad spectrum hemp extract: 25 mg Broad spectrum hemp extract (CBN): 1.5 mg Proprietary blend of Suntheanine (L-Theanine), GadoMag (Magnesium( Sibelius (Camomile) and M2 (Lion's Mane)
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single arm where participants act as their own control Receives: Dietary Supplement: SleepWhale Natural Sleep Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Disturbance Scale
The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals. This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep. Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively.
Unabbreviated Scale Title Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale
Score Range
Short Form (e.g., 8a): 8-40
Score Interpretation
Higher scores = worse sleep disturbance
Lower scores indicate better sleep quality
Measured: Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks (Day 28-32)
Daytime Sleepiness Perception Scale (DSPS-4)
This survey is designed to measure your perception of daytime sleepiness. Please read each statement carefully and circle the response that best applies to your experience.
Score Range
Each item typically scored 0-4 or 1-5
Total score range (most common): 0-16
Score Interpretation
Higher scores = greater perceived daytime sleepiness
Lower scores indicate better daytime alertness
Measured: Change from baseline (Day 1-3) in DSPS-4 at 4 weeks (Day 28-32)
Fatigue Perception and Impact Survey
The Fatigue Perception and Impact Survey (FPIS) is a specialized questionnaire developed to evaluate the presence, severity, and impact of fatigue on an individual's life. Comprising a series of questions, the survey aims to capture both the subjective experience of fatigue and its consequences across various domains, such as physical, emotional, and social aspects. This tool is commonly used in clinical settings to assess fatigue in patients with various medical conditions, including chronic illnesses and cancer, helping healthcare professionals better understand and address the debilitating effects of fatigue on patients' quality of life. Researchers also employ the FPIS to gather valuable data on fatigue patterns.
Score Range 0-4 or 1-5 Likert items Total score range 0-50 Score Interpretation Higher score= worse fatigue and greater functional impact Lower score= less perceived fatigue
Measured: Change from baseline (Day 1-3) in FPIS at 4 weeks (Day 28-32)
Resilience Assessment Scale
This survey aims to evaluate your level of resilience in different situations. Score Range
0-100 (scaled score)
Score Interpretation
Higher scores = greater resilience (better outcome)
Lower scores indicate reduced psychological resilience
Measured: Change from baseline (Day 1-3) in Resilience Assessment Scale at 4 weeks (Day 28-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start25 Aug 2025
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298161
- Sponsor's protocol ID
- 37640
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating SleepWhale Drops for Rest & Resilience
- ClinicalTrials.gov ID
- NCT07298161
- Acronym / sponsor ID
- 37640
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 23 Dec 2025 (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.
30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)-formulated to support deeper sleep and better days.
Detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the efficacy of SleepWhale Natural Sleep Drops (Extra Strength), a non-melatonin sleep aid composed of adaptogens and botanicals, in improving sleep quality and daytime well-being. Recognizing the pervasive issues of sleep disturbances including racing thoughts, restless nights, and sluggish mornings, and the growing interest in natural remedies that provide support without the risk of grogginess or dependency, this study aims to provide empirical evidence on the benefits of SleepWhale.
Participants in this trial will incorporate SleepWhale Drops into their nightly routine for a duration of 30 days. Throughout this period, participants are required to complete weekly check-ins utilizing scientifically validated self-report tools. This approach is chosen to emphasize the subjective experience of sleep quality and daytime functioning over metrics that might be collected by sleep trackers or wearable devices, which, while useful, can sometimes lack accuracy and fail to capture the entirety of an individual's sleep experience.
The primary objective of this study is to assess the impact of regular nightly use of SleepWhale Natural Sleep Drops on several key outcomes, including self-reported sleep quality, incidences of sleep disruption, daytime performance, and overall resilience. By focusing on these areas, the study aims to gather meaningful data that reflects the real-world effectiveness of SleepWhale Drops in supporting restful sleep and enhancing daytime productivity and well-being.
Ultimately, by participating in this trial, individuals will not only contribute to their personal health and well-being but also to the larger body of research aimed at validating the effectiveness of SleepWhale Natural Sleep Drops. This study stands as a critical step towards separating trend from truth, offering participants and the wider community real outcomes and insights into the potential of SleepWhale as a natural solution for better sleep and brighter days.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Dietary Supplement: SleepWhale Natural Sleep DropsSingle arm where participants act as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (10 listed)
- Individuals with Allergies to supplement ingredients
- Individuals on sleep Medication
- Individuals with Gastrointestinal Issues
- Individuals with Skin Conditions
- Individuals Prone to Headaches
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 |
|---|---|---|
| SleepWhale Natural Sleep DropsBroad spectrum hemp extract: 25 mg Broad spectrum hemp extract (CBN): 1.5 mg Proprietary blend of Suntheanine (L-Theanine), GadoMag (Magnesium( Sibelius (Camomile) and M2 (Lion's Mane) | Dietary supplement | Single arm where participants act as their own control |
Primary outcome
PROMIS Sleep Disturbance Scale
Time frame: Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks (Day 28-32)
The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals. This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep. Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively. Unabbreviated Scale Title Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale Score Range Short Form (e.g., 8a): 8-40 Score Interpretation Higher scores = worse sleep disturbance Lower scores indicate better sleep quality
Daytime Sleepiness Perception Scale (DSPS-4)
Time frame: Change from baseline (Day 1-3) in DSPS-4 at 4 weeks (Day 28-32)
This survey is designed to measure your perception of daytime sleepiness. Please read each statement carefully and circle the response that best applies to your experience. Score Range Each item typically scored 0-4 or 1-5 Total score range (most common): 0-16 Score Interpretation Higher scores = greater perceived daytime sleepiness Lower scores indicate better daytime alertness
Fatigue Perception and Impact Survey
Time frame: Change from baseline (Day 1-3) in FPIS at 4 weeks (Day 28-32)
The Fatigue Perception and Impact Survey (FPIS) is a specialized questionnaire developed to evaluate the presence, severity, and impact of fatigue on an individual's life. Comprising a series of questions, the survey aims to capture both the subjective experience of fatigue and its consequences across various domains, such as physical, emotional, and social aspects. This tool is commonly used in clinical settings to assess fatigue in patients with various medical conditions, including chronic illnesses and cancer, helping healthcare professionals better understand and address the debilitating effects of fatigue on patients' quality of life. Researchers also employ the FPIS to gather valuable data on fatigue patterns. Score Range 0-4 or 1-5 Likert items Total score range 0-50 Score Interpretation Higher score= worse fatigue and greater functional impact Lower score= less perceived fatigue
Resilience Assessment Scale
Time frame: Change from baseline (Day 1-3) in Resilience Assessment Scale at 4 weeks (Day 28-32)
This survey aims to evaluate your level of resilience in different situations. Score Range 0-100 (scaled score) Score Interpretation Higher scores = greater resilience (better outcome) Lower scores indicate reduced psychological resilience
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepWhale Natural Sleep Drops in people with Sleep, run by Efforia, Inc 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (646-679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep Disturbance Scale (time frame: Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks (Day 28-32)). 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 23 Dec 2025.