Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:33 PM
Study NCT ID:
NCT02584361
Status:
UNKNOWN
Last Update Posted:
2015-11-02
First Post:
2015-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cochlear Implant and Vestibular Function.
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigate weather one type of cochlear implant (CI) surgery (insertion of the electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI surgery to clarify their vestibular function.
Detailed Description:
Cochlear implant is an advanced type of hearing advice. It consists of an outer microphone, which picks up sound and sends it through an electrode into the cochlear.
With a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back.
Vertigo is one of the most common side effects to cochlear implant surgery. In this study we will investigate if one type of CI surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of CI surgery (cochleostomy).
In the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). Three different surgeons will do the surgeries. All technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically.
Electrodes from Cochlear, MEDEL and AB is being used. We will compare the findings from the vHIT examination with the subject dizziness perceived of the patient.
The patients will be examined before surgery, the day after their surgery and one month after their surgery. The same examinator will perform all the vHIT tests. The test will be performed in continuation of the patient's other visits at the Department of Audiology and Department of Otorhinolaryngology -Head and Neck Surgery.
With a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back.
Vertigo is one of the most common side effects to cochlear implant surgery. In this study we will investigate if one type of CI surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of CI surgery (cochleostomy).
In the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). Three different surgeons will do the surgeries. All technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically.
Electrodes from Cochlear, MEDEL and AB is being used. We will compare the findings from the vHIT examination with the subject dizziness perceived of the patient.
The patients will be examined before surgery, the day after their surgery and one month after their surgery. The same examinator will perform all the vHIT tests. The test will be performed in continuation of the patient's other visits at the Department of Audiology and Department of Otorhinolaryngology -Head and Neck Surgery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: