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临床试验/NCT05183581
NCT05183581已完成不适用

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

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
(De)tumescence duration

研究概览

简要总结

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.

详细描述

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged 18 - 29 years
  • Capable of getting visually arousable erections

排除标准

  • 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

结局指标

主要结局

(De)tumescence duration

时间窗: 10 minutes

Duration of increased penile skin temperature during erection

Temperature increase

时间窗: 10 minutes

Increase in penile skin temperature during erection

次要结局

  • Difference between sexual and nocturnal erections(10 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hille Torenvlied

Coordinating Investigator

St. Antonius Hospital

研究点 (2)

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