RecruitingNot Applicable

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

United States50 participantsStarted 2021-01-29

Plain-language 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)

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Incidental Learning Test scores, evaluating non-verbal recent memory

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Trail Making Test Part A (TMT A) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Trail Making Test Part B (TMT B) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function

Trial details

NCT IDNCT04899037

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Marsadi L. Parliament, Audiologist, Co-Investigator, Au.D.

813-974-1262 marsadi@usf.edu

View on ClinicalTrials.gov More Hearing Loss, Conductive trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Incidental Learning Test scores, evaluating non-verbal recent memory

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Trail Making Test Part A (TMT A) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function

Timeframe: Baseline and Month 36

Change from baseline to month 36 on Trail Making Test Part B (TMT B) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function