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

Description

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)

Conditions

Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Hearing Loss, Conductive
Intervention / Treatment

-

Contacts and Locations

Tampa

Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab, Tampa, Florida, United States, 33613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of South Florida,

Victoria Sanchez, Au.D, Ph.D, PRINCIPAL_INVESTIGATOR, University of South Florida

Morgan Oktela, Au.D, STUDY_DIRECTOR, University of South Florida

Study Record Dates

2025-06