Erectile Dysfunction Clinical Trial
Official title:
Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
NCT number | NCT05183620 |
Other study ID # | 79969 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2022 |
Est. completion date | July 27, 2022 |
Verified date | August 2022 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 27, 2022 |
Est. primary completion date | June 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 29 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Hille Torenvlied | Nieuwegein |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Temperature increase | Increase in penile skin temperature during nocturnal erection | 8 hours | |
Primary | (De)tumescence duration | Duration of increased penile skin temperature during erection | 8 hours | |
Secondary | Difference between sexual and nocturnal erections | Penile and outer thigh temperature increase difference between sexual and nocturnal erection | 8 hours |
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