Status:
RECRUITING
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Oticon Medical
Conditions:
Hearing Loss, Conductive
Hearing Loss, Mixed
Eligibility:
All Genders
18-85 years
Brief Summary
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 second...
Detailed Description
Hearing impairment is highly prevalent and independently associated with cognitive decline. Little is known about the various types, degrees, and configurations of hearing loss and how it relates to u...
Eligibility Criteria
Inclusion
- age 18-85 years
- community dwelling
- residency: participants must plan to reside in the local area for the study duration.
- fluent English-speaker
- Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.
- 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.
- 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)
Exclusion
- self-reported disability in \>2 or more Activities of Daily Living (ADL)
- 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
Key Trial Info
Start Date :
January 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04899037
Start Date
January 29 2021
End Date
June 1 2026
Last Update
October 28 2025
Active Locations (1)
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1
Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab
Tampa, Florida, United States, 33613