Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could

Status Recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Loss, Unilateral

Clinical Trial Details

NCT number	NCT04899037
Study type	Observational
Source	University of South Florida
Contact	Victoria Sanchez, Au.D., Ph.D.
Phone	813-974-1262
Email	vasanchez@usf.edu
Status	Recruiting
Phase
Start date	January 29, 2021
Completion date	June 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms