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Completed

NCT Number: NCT05183581

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

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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Key information

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

About this study

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeling Hot sensor system

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.

Primary outcomes

  1. Temperature increase

    Time frame: 10 minutes

    Increase in penile skin temperature during erection

  2. (De)tumescence duration

    Time frame: 10 minutes

    Duration of increased penile skin temperature during erection

Secondary outcomes

  1. Difference between sexual and nocturnal erections

    Time frame: 10 hours

    Penile and outer thigh temperature increase difference between sexual and nocturnal erection

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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