Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-05 @ 6:21 PM
Study NCT ID:
NCT01600066
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2012-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood specimens for the determination of lipids and glucose'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of erectile function in severe sleep apnea after 6-12 months of CPAP therapy', 'timeFrame': 'at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy', 'description': 'an established self-administered questionnaire is used to assess changes in erectile function occurring after 6-12 months of CPAP therapy in patients with severe sleep apnea'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may reverse erectile dysfunction in affected patients. The present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male patients with untreated severe sleep apnea (apnea-hypopnea-index \\> 30/h)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* apnea-hypopnea-index \\> 30/h\n* no CPAP therapy\n* male gender\n* 18-80 years of age\n* having or attempting to have regular sexual intercourse\n\nExclusion Criteria:\n\n* apnea-hypopnea-index \\< 30/h\n* already treated by CPAP\n* female gender\n* age \\< 18 or \\> 80 years\n* not having or not attempting to have regular sexual intercourse'}, 'identificationModule': {'nctId': 'NCT01600066', 'briefTitle': 'Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Erectile Dysfunction in Severe Obstructive Sleep Apnea : Effects of CPAP Therapy', 'orgStudyIdInfo': {'id': 'GERSAN-1'}, 'secondaryIdInfos': [{'id': 'UGLC', 'type': 'OTHER', 'domain': 'UGLC'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard Schulz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Giessen Lung Center, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Richard Schulz', 'investigatorFullName': 'Richard Schulz', 'investigatorAffiliation': 'University of Giessen'}}}}