Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT04950894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2021-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012913', 'term': 'Snoring'}], 'ancestors': [{'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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'PSG results are masked from the Investigator and Outcomes Assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of response to therapy when compared to no therapy for 6 months', 'timeFrame': 'Month 1 through Month 7', 'description': 'The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.'}, {'measure': 'Rate of all serious adverse device/procedure related events from time of implant through month 7', 'timeFrame': 'Month 1 through Month 7', 'description': 'The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).'}], 'secondaryOutcomes': [{'measure': 'Decrease in Oxygen Desaturation Index (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in Functional Outcomes of Sleep Questionnaire (Efficacy', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in Epworth Sleepiness Scale (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in EQ-5D (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in PROMIS SDI/SRI (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in SF-36 (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Change in CGI-S/CGI-I (Efficacy)', 'timeFrame': 'Baseline through Month 7'}, {'measure': 'Descriptive analysis of all reported Adverse Events (Safety)', 'timeFrame': 'Consent through Month 7'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OSA', 'Snoring', 'Obstructive Sleep Apnea', 'CPAP', 'PAP'], 'conditions': ['Obstructive Sleep Apnea', 'OSA', 'Apnea', 'Apnea, Obstructive', 'Apnea, Obstructive Sleep', 'Apnea+Hypopnea', 'Hypopnea, Sleep']}, 'referencesModule': {'references': [{'pmid': '35613672', 'type': 'DERIVED', 'citation': 'Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016/j.cct.2022.106804. Epub 2022 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.', 'detailedDescription': 'All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.\n\nThe Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)\n\nSafety and efficacy will be evaluated at Month 7, and again at Month 13.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Abbreviated: Additional criteria may apply:\n\nInclusion Criteria:\n\n* Diagnosis of moderate to severe OSA\n* Declines to use or does not tolerate PAP therapy\n\nExclusion Criteria:\n\n* Respiratory, cardiac, renal disease or other co-morbid conditions\n* BMI \\> 35 kg/m2\n* Specific PSG criteria outlined in the protocol'}, 'identificationModule': {'nctId': 'NCT04950894', 'acronym': 'OSPREY', 'briefTitle': 'Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation', 'orgStudyIdInfo': {'id': 'LNS005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13', 'interventionNames': ['Device: Hypoglossal Nerve Stimulation']}, {'type': 'OTHER', 'label': 'Control', 'description': 'HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13', 'interventionNames': ['Device: Hypoglossal Nerve Stimulation']}], 'interventions': [{'name': 'Hypoglossal Nerve Stimulation', 'type': 'DEVICE', 'description': 'Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)', 'armGroupLabels': ['Active', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento Ent', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Paul Schalch Lepe, Md/Silenso Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sleep Medicine Specialists of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34695', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Morton Plant Mease Health Care', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Advanced Ent Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40218', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alivation Research Llc', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10024', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates, Pa', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Ear, Nose and Throat Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants, Llc', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75154', 'city': 'Red Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Epic Medical Research', 'geoPoint': {'lat': 32.51764, 'lon': -96.80444}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Atul Malhotra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD Pulmonary and Critical Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}