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Corticosteroid

Drug-Releasing Cochlear Implant for Hearing Loss (DEE-REX Trial)

N/A

Recruiting

Research Sponsored by Cochlear

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Previously reported diagnosis of bacterial meningitis

Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve, affecting the ear to be implanted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative baseline, 3-, 6- and 12-months postactivation

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cochlear implant called CI632D that slowly releases a drug called dexamethasone to reduce inflammation and tissue injury after surgery. The study aims to see if this

Who is the study for?

Adults with sensorineural hearing loss, which is caused by damage to the inner ear or auditory nerve, are eligible for this trial. Participants must be suitable candidates for cochlear implant surgery.

What is being tested?

The study tests a new cochlear implant (CI632D) that releases dexamethasone to reduce inflammation and tissue injury post-surgery. The aim is to see if it improves hearing more effectively than standard implants.

What are the potential side effects?

Potential side effects may include typical surgical risks associated with cochlear implants, plus any specific reactions related to dexamethasone such as increased risk of infection, mood changes, or elevated blood sugar levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bacterial meningitis before.

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I have brain lesions or deafness in the ear I plan to have an implant in.

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I have an active autoimmune disease or am on immunosuppressive therapy.

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I have been diagnosed with hearing nerve issues in my ear that will be implanted.

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I am allergic to dexamethasone or corticosteroids.

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I have been diagnosed with LVAS, Meniere's disease, or cochlear hydrops in the ear I plan to have implanted.

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My ear does not have conditions that would prevent full electrode insertion.

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I have a hole in my eardrum or had ear surgery in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative baseline, 3-, 6- and 12-months postactivation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative baseline, 3-, 6- and 12-months postactivation

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative baseline, 3-, 6- and 12-months postactivation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation

Coprimary endpoint 2: Mean change in word recognition score in the preferred unilateral listening mode in quiet from preimplantation to 3 months postactivation

Secondary study objectives

Mean change in sentence recognition score in the preferred bilateral listening mode in noise from preimplantation to postimplantation

Mean change in sentence recognition score in the preferred unilateral listening mode in noise from preimplantation to postimplantation

Mean change in the global score of the Speech, Spatial, and Qualities of hearing scale (SSQ12) from preimplantation to postimplantation

Other study objectives

Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency throughout the study