Evaluating long-term effects of osseointegrated devices on hearing and cognition
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
University of South Florida · NCT04899037
This study is trying to see how using special hearing devices affects the thinking and daily life of people with hearing loss over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of South Florida (other) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04899037 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term cognitive and functional outcomes of patients with hearing loss who utilize osseointegrated devices (OID) compared to those who do not. Participants aged 18-85 will be followed for three years to evaluate changes in global cognitive function, hearing performance, quality of life, and social interactions. The study will focus on individuals with conductive, mixed, or unilateral hearing loss and will analyze the impact of OID intervention on various secondary outcomes. The research seeks to fill gaps in understanding the relationship between hearing interventions and cognitive decline.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 18-85 with specific types of hearing impairment who are fluent in English and at risk for cognitive decline.
Not a fit: Patients with significant disabilities in daily living activities or those with substantial cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how osseointegrated devices may improve cognitive function and quality of life for patients with hearing loss.
How similar studies have performed: While there is limited research specifically on osseointegrated devices and cognitive outcomes, similar studies have shown promising results in the relationship between hearing interventions and cognitive health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Victoria Sanchez, Au.D, Ph.D — University of South Florida
- Study coordinator: Marsadi L. Parliament, Audiologist, Co-Investigator, Au.D.
- Email: marsadi@usf.edu
- Phone: 813-974-1262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral, osseointegrated device, cognition, hearing loss, neurocognitive, BAHA