Single-Sided DeafnessNCT06189274
Anatomy Based Selection of CI Array for SSD Patients
A study testing Anatomy-Based Electrode Array Selection in people with Single-Sided Deafness, run by Nova Scotia Health Authority.
Trial summary
The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single-Sided Deafness
- What is being tested?
- Anatomy-Based Electrode Array Selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2025
- 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
- 18 years of age or older at the time of implantation
- Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater
- Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less
- Deemed an appropriate candidate by the investigator
- Fluent in English
Who cannot join
- Duration of profound hearing loss of 10 years or more
- Sudden onset of hearing loss within six months of implantation
- Evidence of non-functional cochlear nerve using appropriate imaging modality to be determined by the investigator
- Other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- External or middle ear infection
- Suspected developmental or cognitive concern
- Other medical contraindication for surgery or anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anatomy-Based Cochlear Implant Array Selection for Patients With Single-Sided Deafness
The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.
Read the detailed description
To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.
Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.
All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.
- Conditions
- Single-Sided Deafness
- Being tested
- Anatomy-Based Electrode Array Selection, Standard of Care Electrode Array Selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomy-Based Electrode Array SelectionOther
Also called OTOPLAN
Use of pre-operative imaging to select the appropriate length electrode vs standard of care
Standard of Care Electrode Array SelectionOther
Use of standard of care electrode which is the FLEX 28 electrode
| Study group | Role | What they receive |
|---|---|---|
| Anatomy-Based Electrode Selection | Experimental | For individuals in the anatomy-based electrode (ABE) group, magnetic resolution imaging (MRI) or computed tomography (CT) scans will be evaluated by MED-EL Canada employees. Based on these results, an appropriate electrode array will be selected. Receives: Other: Anatomy-Based Electrode Array Selection |
| Standard of Care Electrode Selection | Active comparator | The comparison in this study will be to current standard of care, which is to select a single electrode length for most patients, in this case the FLEX28 electrode, which is 28 mm long. Receives: Other: Standard of Care Electrode Array Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech perception in spatially separated noise
Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear
Measured: 6 months post activation
Secondary outcomes (4)
Speech perception in noise
Change in percent correct on the AzBio sentences in noise, in two conditions. Condition 1 is with speech and noise both presented to the front. Condition 2 is with speech presented from the front and noise presented to the CI ear
Measured: 6 months post activation
Speech perception in quiet
Change in percent correct on the CNC words in quiet in implanted ear.
Measured: 6 months post activation
Speech Spatial and Qualities of Hearing Scale (SSQ)
Subjective questionnaire on speech perception and sound quality
Measured: 6 months post activation
Datalogging
Evaluate average daily device use
Measured: 6 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Med-El Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189274
- Sponsor's protocol ID
- NSHSCMEDEL
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy-Based Cochlear Implant Array Selection for Patients With Single-Sided Deafness
- ClinicalTrials.gov ID
- NCT06189274
- Acronym / sponsor ID
- NSHSCMEDEL
- Conditions
- Single-Sided Deafness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Med-El Corporation
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jan 2024 (actual)
- 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.
The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.
Detailed description
To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.
Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.
All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomy-Based Electrode Selection | Experimental | Other: Anatomy-Based Electrode Array SelectionFor individuals in the anatomy-based electrode (ABE) group, magnetic resolution imaging (MRI) or computed tomography (CT) scans will be evaluated by MED-EL Canada employees. Based on these results, an appropriate electrode array will be selected. |
| Standard of Care Electrode Selection | Active comparator | Other: Standard of Care Electrode Array SelectionThe comparison in this study will be to current standard of care, which is to select a single electrode length for most patients, in this case the FLEX28 electrode, which is 28 mm long. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older at the time of implantation
- Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater
- Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less
- Deemed an appropriate candidate by the investigator
- Fluent in English
Key exclusion criteria (8 listed)
- Duration of profound hearing loss of 10 years or more
- Sudden onset of hearing loss within six months of implantation
- Evidence of non-functional cochlear nerve using appropriate imaging modality to be determined by the investigator
- Other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
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 |
|---|---|---|
| Anatomy-Based Electrode Array SelectionAlso: OTOPLANUse of pre-operative imaging to select the appropriate length electrode vs standard of care | Other | Anatomy-Based Electrode Selection |
| Standard of Care Electrode Array SelectionUse of standard of care electrode which is the FLEX 28 electrode | Other | Standard of Care Electrode Selection |
Primary outcome
Speech perception in spatially separated noise
Time frame: 6 months post activation
Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear
4 secondary outcomes
Speech perception in noise
Time frame: 6 months post activation
Speech perception in quiet
Time frame: 6 months post activation
Speech Spatial and Qualities of Hearing Scale (SSQ)
Time frame: 6 months post activation
Datalogging
Time frame: 6 months post activation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Single-Sided Deafness
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Hearing Loss, Unilateral, Deafness, Unilateral
Active, not recruiting
Pediatric Expansion Study of the Sentio System
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
Cochlear Implant, Sensorineural Hearing Loss
Recruiting
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
Sensorineural Hearing Loss, Cochlear Implantation
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.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomy-Based Electrode Array Selection in people with Single-Sided Deafness, run by Nova Scotia Health Authority.
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 5 inclusion and 8 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 David P Morris, MD (902-473-1986, dp.morris@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech perception in spatially separated noise (time frame: 6 months post activation). 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 3 Jan 2024.