Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 6:57 AM
Study NCT ID:
NCT03980158
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2019-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tongue protrusion strength', 'timeFrame': 'Up to 60 months after implanation', 'description': 'Tongue protrusion strength (peak pressure in kPa)'}, {'measure': 'Tongue fatigability', 'timeFrame': 'Up to 60 months after implanation', 'description': 'Time to task failure during 50% of peak pressure contraction in seconds'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '31992396', 'type': 'DERIVED', 'citation': 'Wirth M, Unterhuber D, von Meyer F, Hofauer B, Ott A, Edenharter G, Eckert DJ, Heiser C. Hypoglossal nerve stimulation therapy does not alter tongue protrusion strength and fatigability in obstructive sleep apnea. J Clin Sleep Med. 2020 Feb 15;16(2):285-292. doi: 10.5664/jcsm.8184. Epub 2020 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'Upper airway stimulation (UAS) is an effective surgical alternative for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP) therapy. This stimulation could lead to alterations in tongue strength and fatigability which could alter treatment outcome. The aim of the study is to investigate if UAS alters tongue strength and fatigability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of three groups: the first group comprises of patients that have been implanted with selective hypoglossal nerve stimulation system (Inspire II Upper Airway Stimulation System, Inspire Medical Systems, Maple Grove, USA). The second group consists of confirmed OSA patients either being treated conservatively or without treatment. The test group consists of participants with no medical history for OSA and Epworth Sleepiness Scale (ESS) below 11.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* upper airway stimulation group: Upper airway stimulation system implanted at least 4 weeks ago\n* OSA group: OSA confirmed by 18-channel inpatient overnight polysomnography (PSG)\n* test group: No medical history for OSA and Epworth Sleepiness Scale (ESS) below 11\n\nExclusion Criteria:\n\n* history of a neuromuscular disorder\n* previous tongue surgery'}, 'identificationModule': {'nctId': 'NCT03980158', 'briefTitle': 'Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System', 'orgStudyIdInfo': {'id': '425/17S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Upper airway stimulation group'}, {'label': 'OSA group with conservative / no treatment'}, {'label': 'Test group without OSA'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Ear Nose Throat', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}