30 Day

Sleep Improvement and HRV Enhancement with Sleep Whale

STUDY TITLE Sleep Improvement and HRV Enhancement with Sleep Whale
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

Recruitment page preview

Preview

Author edit

Edit

Informed consent

Review

Study author

Patrick Killen

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

The protocol involves incorporating Sleep Whale products to promote restful sleep and enhance heart rate variability (HRV). By focusing on improved sleep quality, participants aim to achieve better recovery and overall wellness. This approach is designed to optimize physiological functions related to sleep and relaxation.

Participant engagement length

30 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$0

Included products & services
Sleepwhale Natural Sleep Drops (Extra Strength): $121
Sleepwhale CBN (cannabinol): $38
Outcome measures
Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

Included Products & Services

Product Name: Sleepwhale Natural Sleep Drops (Extra Strength)

Quantity included: 30

Price: $121.00

Product Description: The extra strength version of our melatonin alternative. Crafted with natural herbs and minerals that target the most critical parts of the sleep journey for your best next-day self.

Product Image:

Ingredients: Serving size 1.0ml
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)

Product Safety: Serving Size: 1.0 ml
Ingredients per Serving:

Broad Spectrum Hemp Extract (CBD): 25 mg

Broad Spectrum Hemp Extract (CBN): 1.5 mg

Proprietary Blend containing:

Suntheanine (L-Theanine)

GadoMag (Magnesium)

Sibelius (Chamomile extract)

M2 (Lion’s Mane mushroom)

Intended Use:
A natural sleep support supplement formulated to promote relaxation, reduce stress, and support restful sleep.

Ingredient Safety Overview:

CBD (Broad Spectrum Hemp Extract): Generally well-tolerated; promotes calm without intoxication. Avoid combining with strong sedatives or certain medications unless approved by a healthcare provider.

CBN: Known for mild sedative effects. Considered safe in low doses; not recommended during pregnancy or breastfeeding due to limited research.

L-Theanine (Suntheanine): Reduces stress and promotes mental calm. Non-sedating and non-habit forming.

Magnesium (GadoMag): Supports muscle and nervous system relaxation. Well-tolerated; high doses may cause digestive discomfort.

Chamomile (Sibelius): Traditionally used for sleep and relaxation. Safe for most, but those with ragweed allergies should consult a doctor.

Lion’s Mane (M2): Known for supporting cognition and mood balance. Rare instances of mild digestive upset have been reported.

Cautions:

Not recommended for individuals under 18.

Do not use if pregnant or breastfeeding without medical guidance.

May cause drowsiness; avoid driving or operating machinery after use.

Consult a healthcare provider before use if taking medications for sleep, anxiety, or depression.

Stick to the recommended serving size (1.0 ml per 24 hours), unless otherwise directed by a healthcare professional.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Product Name: Sleepwhale CBN (cannabinol)

Quantity included: 30

Price: $38.00

Product Description: CBN is intended for nighttime use. Take 15 minutes before bedtime for deeper, more restful sleep. This product can be taken with Sleep Drops Regular or Extra Strength if you are looking for more sedation.

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire