NCT02584361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

August 31, 2015

Last Update Submit

October 30, 2015

Conditions

Sensorineural Hearing LossDeafnessHearing Loss

Keywords

Hearing lossCochlear implant

Outcome Measures

Primary Outcomes (1)

  • Vestibular function

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

    1 month

Secondary Outcomes (6)

  • Subjective dizziness

    1 month

  • Dizziness

    1 day

  • Dizziness

    1 month

  • T level

    1 month

  • C level

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Cochleostomy

ACTIVE COMPARATOR

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

Procedure: Cochleostomy

Round window approach

ACTIVE COMPARATOR

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)

Procedure: Round window approach

Interventions

Round window approachPROCEDURE

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).

Also known as: RWA
Round window approach
CochleostomyPROCEDURE

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

Cochleostomy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, DK-Odense, 5000, Denmark

RECRUITING

Related Publications (9)

  • 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.

    PMID: 16942684BACKGROUND

  • 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.

    PMID: 18845035BACKGROUND

  • 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.

    PMID: 18164986BACKGROUND

  • 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.

    PMID: 18807058BACKGROUND

  • 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.

    PMID: 22892806BACKGROUND

  • 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.

    PMID: 25583631BACKGROUND

  • 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.

    PMID: 23630593BACKGROUND

  • 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.

    PMID: 23640087BACKGROUND

  • 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.

    PMID: 25492268BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralDeafnessHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leise Korsager, BSc

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leise Korsager, BSc

CONTACT

+45 223 667 18lekor11@student.sdu.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

August 31, 2015

First Posted

October 22, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

DK(1)