Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis

Study Overview
=================
Brief Summary
-----------------
The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. Healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize erectile dysfunction diagnostics.

Detailed Description
-----------------
Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunctions diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

Official Title
-----------------
Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Feeling Hot sensor system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Aged 18 - 29 years Capable of getting visually arousable erections Exclusion Criteria: Test subject unwilling to sign informed consent Test subject with erectile dysfunction IIEF-5 score below 17 Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Visually aroused erection (naked, clothing, blankets)<br>Randomisation of the order of visually aroused erection will be conducted: Naked - Naked & Blanket - Clothing & Blanket Naked - Clothing & Blanket - Naked & Blanket Naked & Blanket - Naked - Clothing & Blanket Naked & Blanket - Clothing & Blanket - Naked Clothing & Blanket - Naked - Naked & Blanket Clothing & Blanket - Naked & Blanket - Naked | Device: Feeling Hot sensor system<br>* The Feeling Hot sensor system consists of two temperature probes placed on the penis and outer thigh of the test subject to measure skin temperature during erection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature increase | Increase in penile skin temperature during erection | 10 minutes | 
| (De)tumescence duration | Duration of increased penile skin temperature during erection | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between sexual and nocturnal erections | Penile and outer thigh temperature increase difference between sexual and nocturnal erection | 10 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, RigiScan, Nocturnal erection, Penile temperature