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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2022-07-27

Brief Summary

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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.

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Detailed Description

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

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Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Visually aroused erection (naked, clothing, blankets)

Randomisation of the order of visually aroused erection will be conducted:

1. Naked - Naked \& Blanket - Clothing \& Blanket
2. Naked - Clothing \& Blanket - Naked \& Blanket
3. Naked \& Blanket - Naked - Clothing \& Blanket
4. Naked \& Blanket - Clothing \& Blanket - Naked
5. Clothing \& Blanket - Naked - Naked \& Blanket
6. Clothing \& Blanket - Naked \& Blanket - Naked

Group Type OTHER

Feeling Hot sensor system

Intervention Type DEVICE

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.

Interventions

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Feeling Hot sensor system

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes