Clinical Trials Directory

Trials / Completed

CompletedNCT05183581

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
St. Antonius Hospital · Academic / Other
Sex
Male
Age
18 Years – 29 Years
Healthy volunteers
Accepted

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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.

Conditions

Interventions

TypeNameDescription
DEVICEFeeling Hot sensor systemThe 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.

Timeline

Start date
2022-05-17
Primary completion
2022-06-09
Completion
2022-07-27
First posted
2022-01-10
Last updated
2022-08-03

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05183581. Inclusion in this directory is not an endorsement.