[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431511":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":39,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Osseointegrated Device Uptake",null,"The participants in this group will be in the 18-85 year age range who have a hearing loss configuration that would benefit from an OID and choose to uptake an OID.",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Osseointegrated Device Non Uptake","The participants in this group will be in the 18-85 year age range and who a hearing loss configuration that would benefit from an OID but choose to not uptake an OID.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No intervention","This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.",[15,9],[24,27],{"name":25,"affiliation":5,"role":26},"Victoria Sanchez, Au.D, Ph.D","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Marsadi L Parliament, Au.D","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Marsadi L. Parliament, Audiologist, Co-Investigator, Au.D.","CONTACT","813-974-1262","marsadi@usf.edu",{"name":37,"role":33,"phone":34,"phoneExt":10,"email":38},"Morgan Oktela, Audiologist, Au.D.","moktela@usf.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab","RECRUITING","Tampa","Florida","33613","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-82.45843,27.94752,{"lat":52,"lon":51},[55,57],{"name":56,"role":33,"phone":34,"phoneExt":10,"email":35},"Marsadi L Parliament, AuD Co-Investigator, Au.D",{"name":58,"role":33,"phone":34,"phoneExt":10,"email":38},"Morgan Oktela, Au.D.",{"type":26,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Victoria Sanchez (Williams)","Principal Investigator",[63],{"name":64,"class":65},"Oticon Medical","INDUSTRY","100431511","pilot-study-to-evaluate-the-long-term-chronic-care-of-patients-who-could-or-do-utilize-an-osseointegrated-device-oid-100431511",false,"NCT04899037","Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)","Inclusion Criteria:\n\n* age 18-85 years\n* community dwelling\n* residency: participants must plan to reside in the local area for the study duration.\n* fluent English-speaker\n* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.\n* Mini-Mental State Exam (MMSE) score \\> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \\>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.\n* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)\n\nExclusion Criteria:\n\n* self-reported disability in \\>2 or more Activities of Daily Living (ADL)\n* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded","ALL","18 Years","85 Years",{"count":76,"type":77},50,"ESTIMATED","OBSERVATIONAL","The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)",[81,82,83],"Hearing Loss, Conductive","Hearing Loss, Mixed","Deafness, Unilateral",[85,86,87,88,89,90,91,92,93,94],"osseointegrated device","cognition","hearing loss","neurocognitive","BAHA","Ponto","Osseointegrated Bone-Conducting Hearing Protheses","Osia","Osseointegrated Auditory Device","Auditory Wellness","2025-10-24",{"date":97,"type":98},"2025-10-28","ACTUAL",{"date":100,"type":98},"2021-01-29",{"date":102,"type":77},"2026-06",{"name":5,"class":6},1]