Outcome Prediction in Cochlear Implant Recipients

NCT02984748 | Completed

• 1 other identifier: CLTD 5565
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.

Conditions

Hearing Loss

Keywords

cochlear implants; hearing loss

Outcome Measures

Primary Outcomes (2)

• Speech recognition in quiet

  Speech recognition scores in quiet

  Testing over 12 months

• Speech recognition in noise

  Speech recognition scores in noise

  Testing over 12 months

Study Arms (1)

Cochlear Implant Recipients

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

Cochlear Implant Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Cochlear Implant Recipients

You may qualify if:

• Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
• Willing and able to attend the study visits
• Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
• Able to read and understand study documents and follow investigator instructions
• Able to understand and follow study personnel instructions during audiological measurements
• Native speaker in the language used to assess clinical speech perception performance

You may not qualify if:

• \. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.

Sponsors & Collaborators

• The Hearing Cooperative Research Centre: lead
• Cochlear: collaborator
• Attune Hearing: collaborator
• Sydney Cochlear Implant Clinic: collaborator

Study Sites (1)

The HEARing CRC

Melbourne, Victoria, 3010, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 7, 2016
• Study Start: October 7, 2014
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)