Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Recruiting now
Conditions studied: Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral
In brief
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)
Key facts
- Study ID
- NCT04899037
- Run by
- University of South Florida
- People needed
- 50
- Starts
- 2021-01-29
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab — Tampa, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.