Evaluating SleepWhale Drops for Rest & Resilience

NCT07298161 | Recruiting

• 1 other identifier: 37640
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)-formulated to support deeper sleep and better days.

Conditions

Sleep

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Change from baseline (Day 1-3) in Resilience Assessment Scale at 4 weeks (Day 28-32)

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single arm where participants act as their own control

Dietary Supplement: SleepWhale Natural Sleep Drops

Interventions

SleepWhale Natural Sleep Drops DIETARY_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)

Single arm where participants act as their own control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Additional information and join instructions on Efforia

Central Study Contacts

Matthew Amsden

CONTACT

646-679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm observational where participants act as their own control

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 23, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)