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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT04899037
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.

Study Details

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 Dates

Start date
Jan 29, 2021
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Osseointegrated Device Uptake
    The participants in this group will be in the 18-85 year age range who have a hearing loss configuration that would benefit from an OID and choose to uptake an OID.
  • Arm: Osseointegrated Device Non Uptake
    The participants in this group will be in the 18-85 year age range and who a hearing loss configuration that would benefit from an OID but choose to not uptake an OID.

Primary Outcome Measure

Change from baseline to month 36 on Ensuring Speech Understanding Test scores, evaluating a participants ability to hear the examiner during the Neurocognitive Test Battery [ Time Frame: Baseline and Month 36 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials LabTampaFlorida33613
Marsadi L Parliament, AuD Co-Investigator, Au.D
[email protected]
813-974-1262
Morgan Oktela, Au.D.
[email protected]
813-974-1262

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By research site
Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab· Tampa, FL

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