Evaluating SleepWhale Drops for Rest & Resilience

December 19, 2025 updated by: Efforia, Inc
30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)-formulated to support deeper sleep and better days.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Efforia
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Can read and understand English.
  • US resident.
  • Willing and able to follow the requirements of the protocol.

Exclusion Criteria:

  • 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
  • Pregnant or Breastfeeding Individuals
  • Athletes and Competitive Participants
  • Individuals with Dependency Issues
  • Individuals with Dizziness or Fatigue Issues

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm where participants act as their own control
Dietary supplement: SleepWhale Natural Sleep Drops
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks (Day 28-32)
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
Change from baseline (Day 1-3) in DSPS-4 at 4 weeks (Day 28-32)
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
Change from baseline (Day 1-3) in FPIS at 4 weeks (Day 28-32)
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
Change from baseline (Day 1-3) in Resilience Assessment Scale at 4 weeks (Day 28-32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Efforia, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

August 25, 2025

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 37640

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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