Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-22 @ 2:08 AM
Study NCT ID:
NCT02969551
Status:
UNKNOWN
Last Update Posted:
2017-03-20
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008365', 'term': 'Manometry'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of obstruction depending of sleep stage', 'timeFrame': '8'}], 'secondaryOutcomes': [{'measure': 'Comparing the manometry findings to DISE', 'timeFrame': '1 Hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Apnea Syndromes']}, 'descriptionModule': {'briefSummary': 'Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with a diagnosed obstructive sleep apnea Syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apnea-Hypopnea-Index (AHI) ≥ 5.\n\nExclusion Criteria:\n\n* age \\<18 years;\n* body mass index (BMI) of \\>35 kg/m2; active infection;\n* previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (\\> 60g ethanol per day or \\> 150g ethanol per week) or sedatives; illicit drug use;\n* chronic obstructive pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT02969551', 'briefTitle': 'Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE', 'orgStudyIdInfo': {'id': '88/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleep apnea, Manometry and possibly DISE', 'description': 'Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy.', 'interventionNames': ['Device: Manometry and possibly DISE']}], 'interventions': [{'name': 'Manometry and possibly DISE', 'type': 'DEVICE', 'description': 'A Manometry is performed on all patients. After it in some Patient DISE is followed', 'armGroupLabels': ['Sleep apnea, Manometry and possibly DISE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Clemens Heiser, MD', 'role': 'CONTACT', 'email': 'hno@heiser-online.com', 'phone': '+49 89 41409583'}], 'facility': 'Klinik für Hals- Nasen- Ohrenheilkunde', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Clemens Heiser, MD', 'role': 'CONTACT', 'email': 'hno@heiser-online.com', 'phone': '+49 8941409583'}, {'name': 'Günther M Edenharter, MD', 'role': 'CONTACT', 'email': 'g.edenharter@tum.de', 'phone': '+49 89 41405051'}], 'overallOfficials': [{'name': 'Clemens Heiser, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'attending doctor in ENT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}