NCT04899037 Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
| NCT ID | NCT04899037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Hearing Loss, Conductive |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-01-29 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-01-29 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)
Eligibility Criteria
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
Contact & Investigator
Victoria Sanchez, Au.D, Ph.D
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT04899037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Hearing Loss, Conductive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04899037 currently recruiting?
Yes, NCT04899037 is actively recruiting participants. Contact the research team at marsadi@usf.edu for enrollment information.
Where is the NCT04899037 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT04899037 clinical trial?
NCT04899037 is sponsored by University of South Florida. The principal investigator is Victoria Sanchez, Au.D, Ph.D at University of South Florida. The trial plans to enroll 50 participants.