Evaluating SleepWhale Drops for Rest & Resilience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SleepWhale Natural Sleep Drops.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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)
Primary outcome measures
- PROMIS Sleep Disturbance Scale [Time frame: 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)]
- Fatigue Perception and Impact Survey [Time frame: 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Efforia — New York
Identifiers
NCT: NCT07298161 · 37640