Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of South Florida
About this trial
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)
Eligibility criteria
Qualifiers
age 18-85 years
community dwelling
residency: participants must plan to reside in the local area for the study duration.
fluent English-speaker
Disqualifiers
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
Trial design
Treatments tested in this trial
- No intervention
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of South Florida
Lead sponsor
Oticon Medical
Collaborator
Source ClinicalTrials.gov