Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedAugust 3, 2022
August 1, 2022
23 days
December 22, 2021
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Temperature increase
Increase in penile skin temperature during nocturnal erection
8 hours
(De)tumescence duration
Duration of increased penile skin temperature during erection
8 hours
Secondary Outcomes (1)
Difference between sexual and nocturnal erections
8 hours
Study Arms (1)
Nocturnal erection measurement
OTHEROvernight measurements of the temperature of the penile skin and outer thigh will be performed, while simultaneously the penile circumference and rigidity is determined by RigiScan measurements
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy volunteer without (a history of) erectile dysfunction
- Male
- Aged 18 - 29 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hille Torenvlied
Nieuwegein, 3435 CM, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Beck, Dr.,MD.
Urologist, St. Antonius Ziekenhuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinating Investigator
Study Record Dates
First Submitted
December 22, 2021
First Posted
January 10, 2022
Study Start
May 17, 2022
Primary Completion
June 9, 2022
Study Completion
July 27, 2022
Last Updated
August 3, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share