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Completed

NCT Number: NCT05183620

Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

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 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. Simultaneous measurements with the RigiScan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for 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

Hille Torenvlied

Nieuwegein, 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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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 dysfunction 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, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer without (a history of) erectile dysfunction
  • Male
  • Aged 18 - 29 years

Exclusion criteria

  • Test subjects who are unwilling to sign informed consent
  • Test subjects with erectile dysfunction
  • IIEF-5 score of below 17
  • (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
  • (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
  • Usage of sleeping pills or benzodiazepines.

Treatment and study plan

Feeling Hot sensor system

Device

The Feeling Hot sensor system consists of two temperature probes placed on the penis and the outer thigh of the test subject to measure skin temperature during erection

Primary outcomes

  1. Temperature increase

    Time frame: 8 hours

    Increase in penile skin temperature during nocturnal erection

  2. (De)tumescence duration

    Time frame: 8 hours

    Duration of increased penile skin temperature during erection

Secondary outcomes

  1. Difference between sexual and nocturnal erections

    Time frame: 8 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 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool

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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