120 Day
Chilipad Sleep System Impact on Male Fertility Study
| STUDY TITLE | Chilipad Sleep System Impact on Male Fertility Study |
|---|---|
| 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 |
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. |
| 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 |
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: 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
Logging
Logging
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