Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis
Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal
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 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.
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 erection
10 minutes
(De)tumescence duration
Duration of increased penile skin temperature during erection
10 minutes
Secondary Outcomes (1)
Difference between sexual and nocturnal erections
10 hours
Study Arms (1)
Visually aroused erection (naked, clothing, blankets)
OTHERRandomisation of the order of visually aroused erection will be conducted: 1. Naked - Naked \& Blanket - Clothing \& Blanket 2. Naked - Clothing \& Blanket - Naked \& Blanket 3. Naked \& Blanket - Naked - Clothing \& Blanket 4. Naked \& Blanket - Clothing \& Blanket - Naked 5. Clothing \& Blanket - Naked - Naked \& Blanket 6. Clothing \& Blanket - Naked \& Blanket - Naked
Interventions
The Feeling Hot sensor system consists of two temperature probes placed on the penis and outer thigh of the test subject to measure skin temperature during erection.
Eligibility Criteria
You may qualify if:
- Male
- Aged 18 - 29 years
- Capable of getting visually arousable erections
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 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