30 Day
Sleep Quality Enhancement Protocol
| STUDY TITLE | Sleep Quality Enhancement Protocol |
|---|---|
| Submitted under umbrella | |
| 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 | |
| Author edit | |
| Informed consent | |
| Study author |
Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Participants will use SleepWhale Magtein and SleepWhale Natural Sleep Drops together nightly to potentially improve sleep duration and depth. The combination is intended to reduce fatigue and enhance overall sleep quality over a month. The treatment is administered in the evening with a dosage of 1ML per night. |
| 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 Magtein (Magnesium L-Threonate): $68
Sleepwhale Natural Sleep Drops (Extra Strength): $121
|
| 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 |
Preview 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 Magtein (Magnesium L-Threonate)
Quantity included: 30
Price: $68.00
Product Description: Magnesium L-threonate is the only bioavailable magnesium brain health ingredient that has been demonstrated to work by crossing the blood-brain barrier improving sleep and mental health.
Product Image:
Ingredients:
Serving Size 4.0ml
Contains Magtien from 2,000 mg of Magnesium L-Threonate, plus purified water and Glycerin
Product Safety:
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.