Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation (INSPIRE)

Cochlear

Status: Active, not recruiting

Conditions: Hearing Loss

Treatments: Procedure: Cochlear™ Remote care; Procedure: Standard of care; Device: Compatible Implant Series and Compatible Sound Processors

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05552118

CLTD5764

Details and patient eligibility

About

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older (no upper age limit)
• Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant
• Unilaterally implanted with a compatible Cochlear™ implant
• Currently using a compatible Cochlear™ Sound Processor
• 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
• Direct access to a compatible Smart Phone
• Fluent in the languages used for the study, as determined by the investigator
• Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
• Willing and able to provide written informed consent

Exclusion criteria

• Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:

  • Non-monopolar MAPs (bipolar, common ground, variable mode)
  • Dynamic range of <10 Comfortable Level (CL)
  • Hybrid mode enabled
  • Pulse widths >100 µs
  • 10 or more electrodes turned off

• Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances

• Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation

• Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)

• Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator

• Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator

• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling

• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation

• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Cochlear™ Remote care

Experimental group

Description:

Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist.

Treatment:

Device: Compatible Implant Series and Compatible Sound Processors

Procedure: Cochlear™ Remote care

Standard of care

Active Comparator group

Description:

Routine In-clinic care

Treatment:

Device: Compatible Implant Series and Compatible Sound Processors

Procedure: Standard of care