Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    50
  • sponsor
    University of South Florida
Updated on 26 May 2022

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 secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)

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 uptake of a hearing intervention and possible long-term benefits of using the intervention. The purpose of this study is to investigate the comparative effectiveness within an observational study design to determine the long-term effects of hearing intervention, in the form of osseointegrated devices (OID), among patients with either conductive, mixed, or single-sided hearing loss. Participants will be followed for 3 years (36 months) to answer the following aims:

Aim 1: To compare the effect of OID intervention versus no audiological intervention on rates of decline in global cognitive function (primary outcome measure) in 18-85 year-old well-functioning and cognitively-normal older adults with hearing loss. We hypothesize that there will be a significant difference in cognitive function between patients that utilized OID hearing intervention compared to no audiological intervention.

Secondary Aims: To compare the effect of OID intervention on secondary outcomes of hearing, social, mental, physical, and cognitive functioning. We hypothesize that there are significant differences in secondary outcomes between patients that utilized OID hearing intervention compared to no audiological intervention.

Details
Condition Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral
Treatment No intervention
Clinical Study IdentifierNCT04899037
SponsorUniversity of South Florida
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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