Single Sided DeafnessNCT02966366
Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
A study testing Cochlear implant in people with Single Sided Deafness and Tinnitus, run by Oticon Medical at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Sided Deafness, Tinnitus, Cochlear Implant
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Aug 2013to 7 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHRU Lille Hôpital Roger Salengro
Lille
CHU Lyon Hôpital Edouard Herriot
Lyon
Hôpital la Pitié Salpêtrièr
Paris
Hôpital Rothschild
Paris
CHU Rennes Pontchaillou
Rennes
CHU Tours Bretonneau
Tours
About this study
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.
Read the 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.
- Conditions
- Single Sided Deafness, Tinnitus, Cochlear Implant
- Being tested
- Cochlear implant
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implantation | Experimental | Evaluation of tinnitus before and after cochlear implantation Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change for Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation
Measured: 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
change for THI Tinnitus Handicap Inventory scale between pre and post implantation
Measured: 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
Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation
Measured: 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
Change for STSS Subjective Tinnitus Severity Scale between pre and post implantation
Measured: 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 outcomes (2)
Speech in noise intelligibility
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.
Measured: Before cochlear implantation, 6 and 12 after conventional stimulation
Speech in quiet intelligibility with cochlear implant only
Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).
Measured: 6 and 12 after conventional stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start27 Aug 2013
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Sided DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Gnansia, Dr, Study director, Oticon MedicalBruno Frachet, Pr, Principal investigator, Hôpital Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966366
- Sponsor's protocol ID
- PIC_02
- Status last verified
- Aug 2018
- First submitted
- 9 Nov 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
- ClinicalTrials.gov ID
- NCT02966366
- Acronym / sponsor ID
- PIC_02
- Conditions
- Single Sided Deafness, Tinnitus, Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implantation | Experimental | Device: Cochlear implantEvaluation of tinnitus before and after cochlear implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- No Social security affiliation
- Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
- Cochlear ossification
- Middle ear pathology
- Tinnitus not related to deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implant | Device | Cochlear implantation |
Primary outcome
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
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
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
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
2 secondary outcomes
Speech in noise intelligibility
Time frame: Before cochlear implantation, 6 and 12 after conventional stimulation
Speech in quiet intelligibility with cochlear implant only
Time frame: 6 and 12 after conventional stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Single Sided Deafness
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Single-Sided Deafness and Asymmetric Hearing Loss
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Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Gnansia, Dr study director
Oticon Medical
Bruno Frachet, Pr principal investigator
Hôpital Rothschild
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant in people with Single Sided Deafness and Tinnitus, run by Oticon Medical at 6 sites in France.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.