120 Day

Chilipad Sleep System Impact on Male Fertility Study

STUDY TITLE Chilipad Sleep System Impact on Male Fertility Study
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

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Study author

, , Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This study looks at the potential benefits of a temperature-regulated sleep environment on recovery, perceived stress, and male fertility. Participants will use the ChiliPad® Dock Pro Sleep System with Sleep Tracker for a period of 120 days. The aim is to ascertain whether changes in bed temperature can potentially improve male fertility. Participants will track fertility using the Legacy Standard Semen Analysis.

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Participant engagement length

120 Days

Sponsor

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

Cost to participant

$1689

Included products & services
ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker: $0
Standard Semen Analysis: $295
Outcome measures

NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form Survey

PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey

Legacy Standard Semen Analysis

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”

Yes

Recruitment jurisdictions

United States, United Kingdom

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: ChiliPad® Dock Pro Bed Cooling System & Sleep Tracker

Quantity included: 1

Price: $0.00

Product Description: Make your existing mattress cooler so you never wake up hot and tired again. Non-wearable Sleep Tracker allows you to gain insights into your sleep metrics, including HRV, respiratory rate, and sleep staging. ME Bundle(single-zone) includes Dock Pro control unit(1), Chilipad Pro mattress topper(1), Sleep Tracker(1)*. WE Bundle(dual-zone) includes Dock Pro control unit(2), Chilipad Pro mattress topper(1), Sleep Tracker(2)*. *membership required

Product Image:

Ingredients:

Product Safety:

Product Name: Standard Semen Analysis

Quantity included: 2

Price: $295.00

Product Description: Understand your fertility with a comprehensive semen analysis that tests all key metrics of sperm health. Just like a fertility clinic, but from the comfort of your couch. The Legacy kit includes a sterile sample cup, an insulating "vault" for temperature control, transport media to preserve the sample, a tamper-proof strip for secure shipping, and free overnight delivery to the lab.

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

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