Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05973669
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MED-EL Remote Care Multi-Center Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006311', 'term': 'Hearing Disorders'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remote Care Completion', 'timeFrame': 'Up to 6 months post-training', 'description': 'Number and proportion of fully completed Remote Care visits.'}], 'secondaryOutcomes': [{'measure': 'Patient time savings', 'timeFrame': 'Up to 6 months post-training', 'description': 'Average time estimates associated with attending an in-clinic appointment compared to Remote Care completion time.'}, {'measure': 'Patient cost estimates', 'timeFrame': 'Up to 6 months post-training', 'description': 'Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.'}, {'measure': 'Clinician time savings', 'timeFrame': 'Up to 6 months post-training', 'description': 'Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time.'}, {'measure': 'Patient Feedback Survey', 'timeFrame': 'Up to 6 months post-training', 'description': 'Subject satisfaction measured using a custom questionnaire administered after each use of Remote Care. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.'}, {'measure': 'Clinician Feedback Survey', 'timeFrame': 'Mid-enrollment to enrollment completion', 'description': 'Clinician satisfaction measured using a custom questionnaire administered at mid-enrollment and at study completion. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.'}, {'measure': 'Remote hearing assessments', 'timeFrame': 'Up to 6 months post-training', 'description': 'Average remote hearing assessment results compared to standard aided test results obtained at baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cochlear implants', 'telehealth', 'remote care'], 'conditions': ['Hearing Loss, Sensorineural', 'Cochlear Implant', 'Cochlear Implant Recipients', 'Hearing Disorders', 'Cochlear Implants']}, 'referencesModule': {'references': [{'pmid': '34320523', 'type': 'BACKGROUND', 'citation': 'Maruthurkkara S, Case S, Rottier R. Evaluation of Remote Check: A Clinical Tool for Asynchronous Monitoring and Triage of Cochlear Implant Recipients. Ear Hear. 2022 Mar/Apr;43(2):495-506. doi: 10.1097/AUD.0000000000001106.'}, {'pmid': '33555935', 'type': 'BACKGROUND', 'citation': 'Takano K, Kaizaki A, Kimura A, Nomura K, Yamazaki N, Shintani T, Himi T. Telefitting of Nucleus Cochlear Implants: A Feasibility Study. Am J Audiol. 2021 Mar 10;30(1):16-21. doi: 10.1044/2020_AJA-20-00041. Epub 2021 Feb 8.'}, {'pmid': '30741905', 'type': 'BACKGROUND', 'citation': 'Slager HK, Jensen J, Kozlowski K, Teagle H, Park LR, Biever A, Mears M. Remote Programming of Cochlear Implants. Otol Neurotol. 2019 Mar;40(3):e260-e266. doi: 10.1097/MAO.0000000000002119.'}, {'pmid': '29678970', 'type': 'BACKGROUND', 'citation': 'Cullington H, Kitterick P, Weal M, Margol-Gromada M. Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019640. doi: 10.1136/bmjopen-2017-019640.'}, {'pmid': '31056039', 'type': 'BACKGROUND', 'citation': 'Schepers K, Steinhoff HJ, Ebenhoch H, Bock K, Bauer K, Rupprecht L, Moltner A, Morettini S, Hagen R. Remote programming of cochlear implants in users of all ages. Acta Otolaryngol. 2019 Mar;139(3):251-257. doi: 10.1080/00016489.2018.1554264.'}, {'pmid': '30452743', 'type': 'BACKGROUND', 'citation': 'Hughes ML, Sevier JD, Choi S. Techniques for Remotely Programming Children With Cochlear Implants Using Pediatric Audiological Methods via Telepractice. Am J Audiol. 2018 Nov 19;27(3S):385-390. doi: 10.1044/2018_AJA-IMIA3-18-0002.'}, {'pmid': '24675003', 'type': 'BACKGROUND', 'citation': 'Eikelboom RH, Jayakody DM, Swanepoel DW, Chang S, Atlas MD. Validation of remote mapping of cochlear implants. J Telemed Telecare. 2014 Jun;20(4):171-177. doi: 10.1177/1357633X14529234. Epub 2014 Mar 27.'}, {'pmid': '20147864', 'type': 'BACKGROUND', 'citation': 'McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87.'}, {'pmid': '18649152', 'type': 'BACKGROUND', 'citation': 'Ramos A, Rodriguez C, Martinez-Beneyto P, Perez D, Gault A, Falcon JC, Boyle P. Use of telemedicine in the remote programming of cochlear implants. Acta Otolaryngol. 2009 May;129(5):533-40. doi: 10.1080/00016480802294369.'}]}, 'descriptionModule': {'briefSummary': 'MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.', 'detailedDescription': 'This prospective multicenter study will include MED-EL cochlear implant users from the US and Canada. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted with at least one MED-EL cochlear implant\n* ≥ 2 weeks since activation of the cochlear implant\n* Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline\n* Utilizing a compatible audio processor in the SONNET or RONDO product lines\n* Ability to complete app-based hearing assessments\n* Commitment to comply with all study procedures for the duration of the study\n* Access to the internet via a smartphone that meets the following requirements:\n* Android or iOS operating systems\n* A smartphone supporting Bluetooth® 4.2 or higher\n* A minimum of 200 MB free storage space\n\nExclusion Criteria:\n\n* Inability or unwillingness to perform the requirements of the clinical investigation\n* Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care\n* Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator'}, 'identificationModule': {'nctId': 'NCT05973669', 'briefTitle': 'MED-EL Remote Care Multi-Center Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Med-El Corporation'}, 'officialTitle': 'MED-EL Remote Care Multi-Center Feasibility Study', 'orgStudyIdInfo': {'id': 'US2302 MED-EL Remote Care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote cochlear implant support', 'description': 'Participants will use MED-EL Remote Care to test their hearing and device functionality. Participants and clinicians will complete user feedback surveys regarding their experience and time/cost-savings.', 'interventionNames': ['Device: MED-EL Remote Care']}], 'interventions': [{'name': 'MED-EL Remote Care', 'type': 'DEVICE', 'description': 'Remote cochlear implant support', 'armGroupLabels': ['Remote cochlear implant support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Zalenski', 'role': 'CONTACT', 'email': 'hannah-zalenski@uiowa.edu', 'phone': '319-353-8776'}, {'name': 'Camille Dunn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Hughes', 'role': 'CONTACT', 'email': 'hughesar@med.umich.edu', 'phone': '734-998-8119'}, {'name': 'Emily Stucken, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Margaret Richter, AuD', 'role': 'CONTACT', 'email': 'margaret_richter@med.unc.edu', 'phone': '919-966-5251'}, {'name': 'Margaret Dillon, AuD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lauren Siegel, MSc', 'role': 'CONTACT', 'email': 'Lauren.Siegel@lhsc.on.ca', 'phone': '905-906-4599'}, {'name': 'Sumit Agrawal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kassandra Kaminskas, M.CI.Sc', 'role': 'CONTACT', 'email': 'kassandra.kaminskas@sunnybrook.ca', 'phone': '416-480-6100'}, {'name': 'Kassandra Kaminskas, M.CI.Sc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'MED-EL Corporation', 'role': 'CONTACT', 'email': 'research.us@medel.com', 'phone': '1-888-633-3524'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Med-El Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}