Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05183620
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2021-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature increase', 'timeFrame': '8 hours', 'description': 'Increase in penile skin temperature during nocturnal erection'}, {'measure': '(De)tumescence duration', 'timeFrame': '8 hours', 'description': 'Duration of increased penile skin temperature during erection'}], 'secondaryOutcomes': [{'measure': 'Difference between sexual and nocturnal erections', 'timeFrame': '8 hours', 'description': 'Penile and outer thigh temperature increase difference between sexual and nocturnal erection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'RigiScan', 'Nocturnal erection', 'Penile temperature'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 dysfunction 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, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer without (a history of) erectile dysfunction\n* Male\n* Aged 18 - 29 years\n\nExclusion Criteria:\n\n* Test subjects who are unwilling to sign informed consent\n* Test subjects with erectile dysfunction\n* IIEF-5 score of below 17\n* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.\n* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea\n* Usage of sleeping pills or benzodiazepines.'}, 'identificationModule': {'nctId': 'NCT05183620', 'briefTitle': 'Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool', 'orgStudyIdInfo': {'id': '79969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nocturnal erection measurement', 'description': 'Overnight 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', 'interventionNames': ['Device: Feeling Hot sensor system']}], 'interventions': [{'name': 'Feeling Hot sensor system', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Nocturnal erection measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Hille Torenvlied', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Jack Beck, Dr.,MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urologist, St. Antonius Ziekenhuis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Hille Torenvlied', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}