Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-01-25 @ 7:28 AM
Study NCT ID:
NCT06540716
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspire Singapore Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Adverse Events', 'timeFrame': '6 months post-therapy activation', 'description': 'Report of procedure/device/therapy-related adverse events'}, {'measure': 'Therapy Adherence', 'timeFrame': '6 months post-therapy activation', 'description': 'Mean therapy use (hours per day)'}, {'measure': 'Functional Outcomes of Sleep Questionnaire (FOSQ) Score', 'timeFrame': '6 months post-therapy activation', 'description': 'Changes in Functional Outcomes of Sleep Questionnaire (FOSQ). Total score range 5-20, with higher scores indicating better functional status.'}, {'measure': 'Inspiratory Overlap', 'timeFrame': '6 months post-therapy activation', 'description': 'Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)'}], 'primaryOutcomes': [{'measure': 'Inspiratory Overlap', 'timeFrame': '0-3 months post-therapy activation', 'description': 'Percentage (%) of inspiratory overlap as measured by polysomnography (PSG)'}], 'secondaryOutcomes': [{'measure': 'Therapy Effectiveness', 'timeFrame': '6 months post-therapy activation', 'description': 'Change in Apnea-Hypopnea Index (AHI)'}, {'measure': 'Symptom Reduction', 'timeFrame': '6 months post-therapy activation', 'description': 'Mean Epworth Sleepiness Scale (ESS) Score of less than 10. ESS scores range from 0-24 with a score of less than 10 indicating normalized daytime sleepiness.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'OSA', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.', 'detailedDescription': 'Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Diagnosis of moderate to severe OSA (AHI 15-65)\n* Failure of, or intolerance to CPAP\n\nMain Exclusion Criteria:\n\n* Central + mixed apneas \\> 25% of total AHI\n* Presence of complete concentric collapse (CCC)\n* Compromised neurological control of the upper airway.\n\nOther eligibility criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06540716', 'briefTitle': 'Inspire Singapore Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inspire Medical Systems, Inc.'}, 'officialTitle': 'Inspire Singapore Study: Confirmation of Therapy Performance', 'orgStudyIdInfo': {'id': '2022-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hypoglossal nerve stimulation', 'interventionNames': ['Device: Inspire System']}], 'interventions': [{'name': 'Inspire System', 'type': 'DEVICE', 'description': 'Hypoglossal nerve stimulation therapy will be activated at approximately 1 month post-implant.', 'armGroupLabels': ['Hypoglossal nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Siew Chen Ling', 'role': 'CONTACT', 'email': 'siew_chen_ling@nuhs.edu.sg'}, {'name': 'Crystal Cheong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Corrina Kee Pei Yin', 'role': 'CONTACT', 'email': 'corrina.kee.p.y@sgh.com.sg'}, {'name': 'Toh Song Tar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Gwen Gimmestad', 'role': 'CONTACT', 'email': 'gwengimmestad@inspiresleep.com', 'phone': '763-392-9966'}, {'name': 'Mike Swierzewski', 'role': 'CONTACT', 'email': 'michaelswierzewski@inspiresleep.com'}], 'overallOfficials': [{'name': 'Toh Song Tar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inspire Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}