Evaluating SleepWhale Drops for Rest & Resilience

ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEfforia, Inc

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Can read and understand English.

US resident.

Willing and able to follow the requirements of the protocol.

Disqualifiers

Individuals with Allergies to supplement ingredients

Individuals on sleep Medication

Individuals with Gastrointestinal Issues

Individuals with Skin Conditions

Trial design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single arm where participants act as their own controlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Change from baseline (Day 1-3) in PROMIS Sleep Disturbance Scale at 4 weeks (Day 28-32)
2

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

Time frame
Change from baseline (Day 1-3) in DSPS-4 at 4 weeks (Day 28-32)
3

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

Time frame
Change from baseline (Day 1-3) in FPIS at 4 weeks (Day 28-32)
4

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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