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Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

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ClinicalTrials.gov Identifier: NCT02966366
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Brief Summary:
Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

Condition or disease Intervention/treatment Phase
Single Sided Deafness Tinnitus Cochlear Implant Device: Cochlear implant Not Applicable

Detailed Description:

Introduction: Continuous surgical, technological and audiological advances are responsible for the ever improvement of outcomes obtained through cochlear implants (CI) over the last decades. These positive observations have progressively led to the cautious extension of CI indications including patients with single-sided deafness (SSD). SSD patients are characterized by the loss of functional hearing in one ear, causing an impairment of binaural hearing abilities, with important difficulties for sound localization and speech in noise comprehension. These patients also often present invalidating tinnitus in the deaf ear, worsening both their psychological and audiological conditions. Recent studies have reported successful reduction of tinnitus intensity after cochlear implantation. However, most studies included a very limited number of participants and tinnitus evaluation tools. The impact of CI speech perception abilities in SSD is still under debate.

Objective: This study aims to assess the effect of CI electrical stimulation on tinnitus, speech-in-noise and speech-in-quiet abilities in a group of 30 SSD patients.

Methods: After cochlear implantation, patients are stimulated using continuous white noise stimulation in the first month period and thereafter using a conventional stimulation. This was done to investigate the effects of non-meaningful, and therefore only peripheral, stimulation. Outcomes were monitored at 1, 3, 6 and 12 months of CI use. Tinnitus loudness and annoyance were measured with a Visual Analog Scale and tinnitus distress and quality of life were evaluated with tinnitus questionnaires (THI, TRQ and STSS). Speech in noise comprehension was assessed in three different spatial listening configurations and speech in quiet was evaluated through direct connection with the speech processor.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cochlear implantation
Evaluation of tinnitus before and after cochlear implantation
Device: Cochlear implant



Primary Outcome Measures :
  1. Change for Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation [ Time Frame: Change from pre-implantation Visual Analog Scale (VAS) scores on intensity and annoyance at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation ]
  2. change for THI Tinnitus Handicap Inventory scale between pre and post implantation [ Time Frame: Change from pre-implantation scores on Tinnitus Handicap Inventory Scale (THI scale) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation ]
  3. Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation [ Time Frame: Change from pre-implantation scores on Tinnitus Reaction Questionnaire (TRQ) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation ]
  4. Change for STSS Subjective Tinnitus Severity Scale between pre and post implantation [ Time Frame: Change from pre-implantation scores on Subjective Tinnitus Severity Scale (STSS) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation ]

Secondary Outcome Measures :
  1. Speech in noise intelligibility [ Time Frame: Before cochlear implantation, 6 and 12 after conventional stimulation ]

    Comparison of speech intelligibility in noise with and without the speech processor, when measured in free field, with the normal hearing ear unplugged. Performance (% of words correctly repeated) is measured:

    • With two level of noise (Speech to Noise Ratio of -3dB and +5 dB)
    • In three different spatial configurations: (S0N0: signal and noise coming from the front; S0NIC: Signal coming from the front and noise coming from the implanted side; SICN0: Signal coming from the implanted side and noise coming from the front.

  2. Speech in quiet intelligibility with cochlear implant only [ Time Frame: 6 and 12 after conventional stimulation ]
    Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18
  • Profound to total single sided deafness with associated tinnitus
  • Normal or near-normal hearing on contralateral ear
  • Tinnitus evaluated by THI ≥ 58 and VAS on annoyance ≥8
  • Failure of usual tinnitus treatments
  • Duration of tinnitus between 1 and 15 years
  • Normal vestibular function of contralateral ear
  • Native of fluent French speaker

Exclusion Criteria:

  • No Social security affiliation
  • Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
  • Cochlear ossification
  • Middle ear pathology
  • Tinnitus not related to deafness
  • Depression with BDI (Beck Depression Inventory) > 16 or unfavorable advice from psychologist/ psychiatrist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966366


Locations
France
CHRU Lille Hôpital Roger Salengro
Lille, France
CHU Lyon Hôpital Edouard Herriot
Lyon, France
Hôpital la Pitié Salpêtrièr
Paris, France
Hôpital Rothschild
Paris, France
CHU Rennes Pontchaillou
Rennes, France
CHU Tours Bretonneau
Tours, France
Sponsors and Collaborators
Oticon Medical
Investigators
Study Director: Dan Gnansia, Dr Oticon Medical
Principal Investigator: Bruno Frachet, Pr Hôpital Rothschild

Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT02966366     History of Changes
Other Study ID Numbers: PIC_02
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tinnitus
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms