RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2021-01-29
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04899037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 18-85 years
  2. * community dwelling
  3. * residency: participants must plan to reside in the local area for the study duration.
  4. * fluent English-speaker
  5. * Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.
  6. * 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.
  7. * 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)
  1. * self-reported disability in \>2 or more Activities of Daily Living (ADL)
  2. * 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

Contacts and Locations

Study Contact

Victoria Sanchez, Au.D., Ph.D.
CONTACT
813-974-1262
vasanchez@usf.edu
Morgan Oktela, Au.D.
CONTACT
813-974-1262
moktela@usf.edu

Principal Investigator

Victoria Sanchez, Au.D, Ph.D
PRINCIPAL_INVESTIGATOR
University of South Florida
Morgan Oktela, Au.D
STUDY_DIRECTOR
University of South Florida

Study Locations (Sites)

Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab
Tampa, Florida, 33613
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Victoria Sanchez, Au.D, Ph.D, PRINCIPAL_INVESTIGATOR, University of South Florida
  • Morgan Oktela, Au.D, STUDY_DIRECTOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-29
Study Completion Date2025-06

Study Record Updates

Study Start Date2021-01-29
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • osseointegrated device
  • cognition
  • hearing loss
  • neurocognitive

Additional Relevant MeSH Terms

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