Feeling Hot 2: Evaluating nocturnal erection detection with penile temperature measurements in the search of a modern erectile dysfunction diagnostic tool.
Completed
- Conditions
- Erectile dysfunctionerection dysfunction1004048010013355
- Registration Number
- NL-OMON51838
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of the Feeling Hot 2 study is to determine the change in<br /><br>penile skin temperature and increased duration of (de)tumescence during<br /><br>nocturnal erections. With these outcomes, the validity of temperature<br /><br>measurements to detect nocturnal erections can be determined. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome of the Feeling Hot 2 study combines the results of the<br /><br>Feeling Hot 1 study. It is studied what differences in bodily skin temperature<br /><br>exist between nocturnal erections and visually aroused erections. Furthermore,<br /><br>it is studied whether the reference temperature probe placed on the outer thigh<br /><br>can compensate for the environmental influences of blankets and clothing. </p><br>