Sensorineural Hearing Loss (Disorder)NCT01749592
Single-sided Deafness and Cochlear Implants
A study testing cochlear implant in people with Sensorineural Hearing Loss (Disorder), run by University of Zurich at 1 site in Switzerland.
Trial summary
As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensorineural Hearing Loss (Disorder)
- 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
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to 8 Feb 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: • Patients with acquired single sided sensorineural deafness due to cochlear damage.
- Age: 18-70 years old.
- Onset of SSD within 6 months to 10 years before Study inclusion.
- Normal hearing on the contralateral ear (Hearing thresholds 0.125-2 kHz 25 dB HL or better, 4-8 kHz 35 dB HL or better, 100% speech discrimination at 80 dB SPL).
- Regular middle ear function on the hearing ear.
- Regular structure of the cochlea and the cochlear nerve (as demonstrated by MRI, MRI scans are included in the basic assessment of SSD and are no study-specific investigations).
- Fluency in the German language.
- Subject is willing to comply with all study requirements.
- Impairment in daily life as a consequence of SSD (communication problems, annoyance by tinnitus perception).
- Subject is not participating in another ongoing research study related to the SSD.
- Subject does not have unrealistic expectations, regarding the outcome of the intervention.
- Subject has had a trial with conventional acoustic measures in SSD (CROSS, BAHA).
Exclusion criteria: • Uncertainty of correct diagnosis of SSD.
- Retrocochlear cause of SSD (Deafness due to lesions of the acoustic nerve or central auditory pathways).
- Active middle ear infections.
- Ossification of the cochlear that prevents electrode insertion.
- Tympanic membrane perforation.
- Psychiatric comorbidities such as depression or cognitive deficits.
- Severe coexisting illness with a medium survival of less than 5 years.
- Exposure to radiation with a cumulative effective dose of 5 mSV within the last 5 years (including the ongoing year).
- Increased risk profile for general anesthesia due to cardiovascular comorbidity.
- Metallic implants constituting an exclusion criterium for MEG procedures of the brain.
- Pregnancy (a pregnancy test will be performed in women in the reproductive age group before study enrolment and before postoperative PET scan) and lactation.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Otorhinolaryngology ORL
Zurich, Canton of Zurich, 8091
About this study
Official title: Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
- As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
- Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear.
- Multicenter, prospective, open, non-randomized clinical trial with 5 patients with right-sided and 5 patients with left-sided sensineural deafness.
- Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG
- Comparison of pre-operative investigations with 10 healthy subjects (age and gender matched control group)
- Cochlea implantation
- Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization Audiometry, PET, EEG, Questionnaires
- Trial with medical device
Read the detailed description
Postlingual single-sided deafness (SSD) is a type of hearing impairment with normal hearing in one ear and severely impaired hearing in the other ear. The condition induces multiple changes of neural plasticity in central auditory pathways. One manifestation reflects an increased common activation of the contralateral and ipsilateral pathways after stimulation of the normal hearing ear which is correlated with an increased activity between the contralateral and ipsilateral hemispheres. As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual. Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear. It is assumed that some changes induced by SSD can be detected only by reversal through a cochlear implant.
- Conditions
- Sensorineural Hearing Loss (Disorder)
- Being tested
- cochlear implant
- Keywords
- hearing loss, cochlear implant, PET, EEG, MEG
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
Surgical implantation of a cochlear implant device
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant | Experimental | Surgical Implantation of a Cochlear Implant Receives: Device: cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry
Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
Measured: up to12 months after invention
Secondary outcomes (1)
PET scan
[15O] H2O Positron emission tomography (PET) is performed. The comparison of baseline PET scans and stimulated PET scans will demonstrate task related changes in brain activity
Measured: 9 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing Loss (Disorder)Studies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Kleinjung, MD, Principal investigator, University Hospital Zurich, Division of Otorhinolaryngology ORL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749592
- Sponsor's protocol ID
- 2012-0034
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2012
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peter N, Treyer V, Probst R, Kleinjung T. Auditory Cortical Plasticity in Patients with Single-Sided Deafness Before and After Cochlear Implantation. J Assoc Res Otolaryngol. 2024 Feb;25(1):79-88. doi: 10.1007/s10162-024-00928-3. Epub 2024 Jan 22.
PubMed 38253897Peter N, Kleinjung T, Probst R, Hemsley C, Veraguth D, Huber A, Caversaccio M, Kompis M, Mantokoudis G, Senn P, Wimmer W. Cochlear implants in single-sided deafness - clinical results of a Swiss multicentre study. Swiss Med Wkly. 2019 Dec 27;149:w20171. doi: 10.4414/smw.2019.20171. eCollection 2019 Dec 16.
PubMed 31880806
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
- ClinicalTrials.gov ID
- NCT01749592
- Acronym / sponsor ID
- 2012-0034
- Conditions
- Sensorineural Hearing Loss (Disorder)
- Keywords
- hearing loss, cochlear implant, PET, EEG, MEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 13 Dec 2012 (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.
- As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
- Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear.
- Multicenter, prospective, open, non-randomized clinical trial with 5 patients with right-sided and 5 patients with left-sided sensineural deafness.
- Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG
- Comparison of pre-operative investigations with 10 healthy subjects (age and gender matched control group)
- Cochlea implantation
- Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization Audiometry, PET, EEG, Questionnaires
- Trial with medical device
Detailed description
Postlingual single-sided deafness (SSD) is a type of hearing impairment with normal hearing in one ear and severely impaired hearing in the other ear. The condition induces multiple changes of neural plasticity in central auditory pathways. One manifestation reflects an increased common activation of the contralateral and ipsilateral pathways after stimulation of the normal hearing ear which is correlated with an increased activity between the contralateral and ipsilateral hemispheres. As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual. Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear. It is assumed that some changes induced by SSD can be detected only by reversal through a cochlear implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant | Experimental | Device: cochlear implantSurgical Implantation of a Cochlear Implant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 implantSurgical implantation of a cochlear implant device | Device | Cochlear Implant |
Primary outcome
Audiometry
Time frame: up to12 months after invention
Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
1 secondary outcome
PET scan
Time frame: 9 months after intervention
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 9 Sep 2020.
- Derived from this study: PubMed 38253897Peter N, Treyer V, Probst R, Kleinjung T. Auditory Cortical Plasticity in Patients with Single-Sided Deafness Before and After Cochlear Implantation. J Assoc Res Otolaryngol. 2024 Feb;25(1):79-88. doi: 10.1007/s10162-024-00928-3. Epub 2024 Jan 22.
- Derived from this study: PubMed 31880806Peter N, Kleinjung T, Probst R, Hemsley C, Veraguth D, Huber A, Caversaccio M, Kompis M, Mantokoudis G, Senn P, Wimmer W. Cochlear implants in single-sided deafness - clinical results of a Swiss multicentre study. Swiss Med Wkly. 2019 Dec 27;149:w20171. doi: 10.4414/smw.2019.20171. eCollection 2019 Dec 16.
- Individual participant dataSharing planned: No
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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.
Tobias Kleinjung, MD principal investigator
University Hospital Zurich, Division of Otorhinolaryngology ORL
1 site 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 Sensorineural Hearing Loss (Disorder), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Sep 2020. 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 Switzerland. 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?
Audiometry (time frame: up to12 months after invention). 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 NCT01749592, which also lists 2 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 9 Sep 2020.