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Cochlear Implant and Vestibular Function.

Primary Purpose

Sensorineural Hearing Loss, Deafness, Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Round window approach
Cochleostomy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Hearing loss, Cochlear implant

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • deaf or severe hard of hearing
  • normal or slightly affected vestibular function (gain >0,50)

Exclusion Criteria:

  • subjects with otosclerosis
  • subject who will have the CI surgery for preservation of the residual hearing

Sites / Locations

  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cochleostomy

Round window approach

Arm Description

In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).

In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA)

Outcomes

Primary Outcome Measures

Vestibular function
Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation

Secondary Outcome Measures

Subjective dizziness
Measured by Dizziness Handicap Inventory Score (DHI).
Dizziness
Measured by a visuel analog scale (VAS) the day after cochlear implant surgery.
Dizziness
Measured by a visuel analog scale (VAS) in connection with consultation for CI activation.
T level
T level is a electropsysiological value. It is the minimum electrical signal in the electrode required for the patient to sense sound.
C level
C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound.
NRT level
Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically.

Full Information

First Posted
August 31, 2015
Last Updated
October 30, 2015
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02584361
Brief Title
Cochlear Implant and Vestibular Function.
Official Title
Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Deafness, Hearing Loss
Keywords
Hearing loss, Cochlear implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cochleostomy
Arm Type
Active Comparator
Arm Description
In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Arm Title
Round window approach
Arm Type
Active Comparator
Arm Description
In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA)
Intervention Type
Procedure
Intervention Name(s)
Round window approach
Other Intervention Name(s)
RWA
Intervention Description
In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA).
Intervention Type
Procedure
Intervention Name(s)
Cochleostomy
Intervention Description
In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Primary Outcome Measure Information:
Title
Vestibular function
Description
Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Subjective dizziness
Description
Measured by Dizziness Handicap Inventory Score (DHI).
Time Frame
1 month
Title
Dizziness
Description
Measured by a visuel analog scale (VAS) the day after cochlear implant surgery.
Time Frame
1 day
Title
Dizziness
Description
Measured by a visuel analog scale (VAS) in connection with consultation for CI activation.
Time Frame
1 month
Title
T level
Description
T level is a electropsysiological value. It is the minimum electrical signal in the electrode required for the patient to sense sound.
Time Frame
1 month
Title
C level
Description
C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound.
Time Frame
1 month
Title
NRT level
Description
Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: deaf or severe hard of hearing normal or slightly affected vestibular function (gain >0,50) Exclusion Criteria: subjects with otosclerosis subject who will have the CI surgery for preservation of the residual hearing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leise Korsager, BSc
Phone
+45 223 667 18
Email
lekor11@student.sdu.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leise Korsager, BSc
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
DK-Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leise Korsager, BSc
Phone
+45 223 667 18
Email
lekor11@student.sdu.dk
First Name & Middle Initial & Last Name & Degree
Jens Wanscher, MD
Email
jens.hoejberg.wanscher@rsyd.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
16942684
Citation
Wanscher JH, Faber CE, Grontved AM. [Cochlear implantation in deaf adults: effect on quality of life]. Ugeskr Laeger. 2006 Aug 14;168(33):2656-9. Danish.
Results Reference
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PubMed Identifier
18845035
Citation
Ovesen T, Johansen LV. Post-operative problems and complications in 313 consecutive cochlear implantations. J Laryngol Otol. 2009 May;123(5):492-6. doi: 10.1017/S0022215108003691. Epub 2008 Oct 10.
Results Reference
background
PubMed Identifier
18164986
Citation
Todt I, Basta D, Ernst A. Does the surgical approach in cochlear implantation influence the occurrence of postoperative vertigo? Otolaryngol Head Neck Surg. 2008 Jan;138(1):8-12. doi: 10.1016/j.otohns.2007.09.003.
Results Reference
background
PubMed Identifier
18807058
Citation
Krause E, Louza JP, Hempel JM, Wechtenbruch J, Rader T, Gurkov R. Effect of cochlear implantation on horizontal semicircular canal function. Eur Arch Otorhinolaryngol. 2009 Jun;266(6):811-7. doi: 10.1007/s00405-008-0815-5. Epub 2008 Sep 20.
Results Reference
background
PubMed Identifier
22892806
Citation
Richard C, Fayad JN, Doherty J, Linthicum FH Jr. Round window versus cochleostomy technique in cochlear implantation: histologic findings. Otol Neurotol. 2012 Sep;33(7):1181-7. doi: 10.1097/MAO.0b013e318263d56d.
Results Reference
background
PubMed Identifier
25583631
Citation
Sun CH, Hsu CJ, Chen PR, Wu HP. Residual hearing preservation after cochlear implantation via round window or cochleostomy approach. Laryngoscope. 2015 Jul;125(7):1715-9. doi: 10.1002/lary.25122. Epub 2015 Jan 13.
Results Reference
background
PubMed Identifier
23630593
Citation
Macdougall HG, McGarvie LA, Halmagyi GM, Curthoys IS, Weber KP. The video Head Impulse Test (vHIT) detects vertical semicircular canal dysfunction. PLoS One. 2013 Apr 22;8(4):e61488. doi: 10.1371/journal.pone.0061488. Print 2013.
Results Reference
background
PubMed Identifier
23640087
Citation
Havenith S, Lammers MJ, Tange RA, Trabalzini F, della Volpe A, van der Heijden GJ, Grolman W. Hearing preservation surgery: cochleostomy or round window approach? A systematic review. Otol Neurotol. 2013 Jun;34(4):667-74. doi: 10.1097/MAO.0b013e318288643e.
Results Reference
background
PubMed Identifier
25492268
Citation
Zawawi F, Alobaid F, Leroux T, Zeitouni AG. Patients reported outcome post-cochlear implantation: how severe is their dizziness? J Otolaryngol Head Neck Surg. 2014 Dec 10;43(1):49. doi: 10.1186/s40463-014-0049-z. eCollection 2014.
Results Reference
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Cochlear Implant and Vestibular Function.

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