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AzTrials

Sensorineural Hearing LossNCT02584361

Cochlear Implant and Vestibular Function.

A study testing Round window approach and Cochleostomy in people with Sensorineural Hearing Loss and Deafness, run by Odense University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Sensorineural Hearing Loss, Deafness, Hearing Loss
What is being tested?
Round window approach and Cochleostomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteDenmark
Study dates
Aug 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Leise Korsager, BSc contact

+45 223 667 18

lekor11@student.sdu.dk

Denmark1 site, 1 recruiting

  • Odense University Hospital

    Odense, DK-Odense, 5000

    Leise Korsager, BSc, +45 223 667 18, lekor11@student.sdu.dk

    Jens Wanscher, MD, jens.hoejberg.wanscher@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

Official title: Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.

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.

Read the 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.

Being tested
Round window approach, Cochleostomy
Keywords
Hearing loss, Cochlear implant
Medical subject headings
Hearing Loss, Sensorineural, Deafness, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Round window approachProcedure or surgery

    Also called RWA

    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).

  • CochleostomyProcedure or surgery

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

Study groups in NCT02584361
Study groupRoleWhat they receive
CochleostomyActive comparatorIn this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Receives: Procedure: Cochleostomy
Round window approachActive comparatorIn 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)
Receives: Procedure: Round window approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vestibular function

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

    Measured: 1 month

Secondary outcomes (6)

  1. Subjective dizziness

    Measured by Dizziness Handicap Inventory Score (DHI).

    Measured: 1 month

  2. Dizziness

    Measured by a visuel analog scale (VAS) the day after cochlear implant surgery.

    Measured: 1 day

  3. Dizziness

    Measured by a visuel analog scale (VAS) in connection with consultation for CI activation.

    Measured: 1 month

  4. T level

    T level is a electropsysiological value. It is the minimum electrical signal in the electrode required for the patient to sense sound.

    Measured: 1 month

  5. C level

    C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound.

    Measured: 1 month

  6. NRT level

    Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584361
Sponsor's protocol ID
47190
Status last verified
Oct 2015
First submitted
31 Aug 2015
Last updated
2 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16942684

  • 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.

    PubMed 18845035

  • 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.

    PubMed 18164986

  • 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.

    PubMed 18807058

  • 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.

    PubMed 22892806

  • 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.

    PubMed 25583631

  • 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.

    PubMed 23630593

  • 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.

    PubMed 23640087

  • 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.

    PubMed 25492268

Questions about this trial

What is this clinical trial studying?

A study testing Round window approach and Cochleostomy in people with Sensorineural Hearing Loss and Deafness, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leise Korsager, BSc (+45 223 667 18, lekor11@student.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vestibular function (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584361, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.

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