Cochlear ImplantsNCT03694340
Optimization of Cochlear Implant MAP-parameters in Children
A study testing Re-programming of cochlear implant in people with Cochlear Implants and Evoked Potentials, Auditory, run by Göteborg University at 1 site in Sweden.
Trial summary
This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants, Evoked Potentials, Auditory, Child
- What is being tested?
- Re-programming of cochlear implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 25 Oct 2018to 30 Jun 2020
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cochlear implant by Cochlear Ltd type: CI24RE or newer
- Received cochlear implant before three years of age
- Have carried out hearing tests with tones and speech recognition
Who cannot join
- Malformation of the cochlea
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses
Gothenburg, 40530
About this study
Official title: Optimization of Cochlear Implant MAP-parameters in Children, Reprogramming Based on Active Co-operation
This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements.
At Sahlgrenska University Hospital in Gothenburg, generally, all younger children (0-3 years), the last ten years, had their CI's programmed based on objective measurements. The programming of the CI carried out during the first year after the surgical insertion is done on the foundation of the objective measurements and is generally what the child will live with thereafter. This method also seem to be close to other clinics in Sweden and the rest of the world, however, there are no specific guidelines regarding the how the programming of the CI is to be carried out on small children. To this date there are no studies, to our knowledge, that have confirmed the validity of using these objective measurements and if it is the best for the child. We therefore aim to do a long term follow up on children that have received CI and programmed this way, and study if there would be beneficial to redo the programming when the child is old enough to actively participate.
Read more
The aim with this project is evaluate how suitable it is to mainly use objective measurements when programming the cochlear implant and, in addition to this, examine if the children's hearing can be improved if the programming is based on the behavioral measurements of sound when the children are old enough to participate in such. It will examine what happens with the end result if the programming foundation differentiates from one another; if there are any measurable differences in hearing skills.
The result from this project expects to generate knowledge that is highly important for those working with small children receiving CI's, and by extension it will benefit the children that rely on this device in there every day life.
Read the detailed description
Cochlear implants (CI) enable hearing for persons who otherwise would have been deaf. A CI substitutes the sensory cells in the cochlea and stimulates the auditory nerve directly with weak electrical pulses. For children born deaf, or become deaf at an early age, prompt detection of this condition is important to since it enables the possibility of an early implantation of the CI and facilitates the child's development of a spoken language. When it comes to detecting deafness in newborns, Sweden has a well-functioning and widespread hearing screening program for infants, permitting children born deaf, or with severe hearing impairments, to be discovered very early. In general, children that are born deaf can get a CI implanted at about one year of age, if there are no other contraindications. Internationally it has become increasingly common for implants to be inserted at even lower ages, sometimes even as young as five months of age.
For small children who receive CI's at an early age it is not possible to perform measurements based on the child making subjective assessments of how the sound is perceived when the electrical stimulation is altered through the implant. Also, small children cannot judge and report back the quality of the sound. Instead, objective measurements are commonly used since they do not require the active participation of the child, along with observations of the child and how it spontaneously reacts to the sound stimulation. A common objective measurement is to find the lowest level of electrical stimulation required to obtain a response from the auditory nerve, i.e. the electrically evoked action potential (ECAP) threshold. The CI manufacturer Cochlear Ltd has developed an automatic system for this measurement. Based on such measurements, as the automatic ECAP-measurement, the electrical stimulation from the implant can adjusted to the so-called MAP, where the minimum and maximum stimulation levels (T- respectively C-levels) are set for each individual electrode on the implant to create the dynamic range of electrical stimulation. This MAP then becomes the basis for the child's ability to perceive sound.
Clinically, today (at Sahlgrenska University Hospital, Gothenburg, Sweden) a basic programming of the MAP is performed based on ECAP measurements, after which adjustment of only the overall level is carried out based on the child's reactions. However, no subjective measurement is made regarding threshold levels of stimulation through the implant or that the child actually perceives medium sound equally across the different channels. When the child can participate in sound field audiometry, adjustments of the MAP settings are made to get a straight audiogram, but basically, the children continue to use the setting based on the ECAP measurement. Adult patients with acquired deafness receiving CI are managed in a different manner than the children. The programming of the implant for adults is based on subjective measurements of how stimulation via individual electrodes is perceived. By measuring thresholds for individual electrodes, i.e. minimum audible stimulation (T-levels) and levels where stimulation is immediately below unpleasant strong (C-levels), then the MAP is programmed with an individual dynamic range for each electrode.
To our knowledge no previous study have explored how the MAP based on an ECAP measurement endures over time or if a re-programming should be carried out when the child reliably can participate in behavioral measurements, which is about seven years of age in terms of measuring T-levels. Studies have shown that there is a correlation between ECAP-thresholds and T- and C-levels for people who can participate actively. However, the relationship is relatively weak and some researchers have even considered it too weak for ECAP thresholds to be the basis for programming the implant. However, in most clinics, these thresholds are used as a basis for programming CI to small children.
Several of those who work with programming the MAP in small children claims to witness an adaptation in sensitivity of the auditory nerve to the applied stimulation; indicating that the results of the objective measurement could gradually change if there is an alternation in stimulation levels. However, there are no studies at this time that neither confirm nor deny this.
The aim of this project is to investigate and clarify how children who receive CI at an early age should be monitored and to evaluate the objective ECAP measurement as a basis for setting stimulation levels. It also aims to investigate if there is any change in the result of the ECAP measurement after adjustment has been made in the MAP. After completion of the study, the goal is to offer a better and more knowledge-based (re-) habilitation for children who receive CI's, for whom there are currently no definite guidelines for programming and follow-up.
- Conditions
- Cochlear Implants, Evoked Potentials, Auditory, Child, Disabilities Hearing, Deafness, Hearing
- Being tested
- Re-programming of cochlear implant
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-programming of cochlear implantOther
New MAP based on behavioral T- and C-levels
| Study group | Role | What they receive |
|---|---|---|
| Re-programming of cochlear implant | Other | The cochlear implant is programmed with a new MAP based on behavioral measurements of T- and C-levels and used by the participant for 4 months before follow up. Receives: Other: Re-programming of cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in speech perception
Sound field hearing test performed with a pre-recorded speech material consisting of everyday sentences.
Measured: Performed at baseline and 4 months after intervention
Change in tone threshold
Sound field hearing test performed with tones to determine hearing thresholds.
Measured: Performed at baseline and 4 months after intervention
Behavioral T-thresholds
Behavioral measurements of the T-levels that constitutes the the lower level of the dynamic range when programming the cochlear implant (setting the MAP).
Measured: Performed at intervention
Behavioral C-thresholds
Behavioral measurements of the C-levels that constitutes the upper level of the dynamic range when programming the cochlear implant (setting the MAP).
Measured: Performed at intervention
Change in automatically recorded electrical evoked action potential thresholds
The measurement used for programming the cochlear implant if not behavioral measurements are feasible (e.g. small children).
Measured: Performed at baseline and 4 months after intervention
Secondary outcomes (1)
Change in results from "Children's Home Inventory for Listening Difficulties" questionnaire
The questionnaire "Children's Home Inventory for Listening Difficulties" assesses the subjective effect on the child's hearing of the re-programming of the cochlear implant. The questionnaire refers both the participant (the child) and the caregiver separately, and consists of 15 questions of different everyday hearing situation. Each question is answered on a rating scale of 1 - 8; a higher grading indicates better hearing (i.e. better outcome). The result is presented as a mean of all the ratings for the participant and the caregiver, respectively.
Measured: Performed at baseline and 4 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 posted3 Oct 2018
- Study start25 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case research design
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Lennart Magnusson, PhD, Principal investigator, Sahlgrenska University Hospital, Region Västra Götaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694340
- Sponsor's protocol ID
- VGRFOU-247791
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2018
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roland JT Jr, Cosetti M, Wang KH, Immerman S, Waltzman SB. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009 Nov;119(11):2205-10. doi: 10.1002/lary.20489.
PubMed 19507225de Vos JJ, Biesheuvel JD, Briaire JJ, Boot PS, van Gendt MJ, Dekkers OM, Fiocco M, Frijns JHM. Use of Electrically Evoked Compound Action Potentials for Cochlear Implant Fitting: A Systematic Review. Ear Hear. 2018 May/Jun;39(3):401-411. doi: 10.1097/AUD.0000000000000495.
PubMed 28945656Abbas PJ, Brown CJ, Shallop JK, Firszt JB, Hughes ML, Hong SH, Staller SJ. Summary of results using the nucleus CI24M implant to record the electrically evoked compound action potential. Ear Hear. 1999 Feb;20(1):45-59. doi: 10.1097/00003446-199902000-00005.
PubMed 10037065Botros A, van Dijk B, Killian M. AutoNR: an automated system that measures ECAP thresholds with the Nucleus Freedom cochlear implant via machine intelligence. Artif Intell Med. 2007 May;40(1):15-28. doi: 10.1016/j.artmed.2006.06.003. Epub 2006 Aug 22.
PubMed 16920343Plant K, Law MA, Whitford L, Knight M, Tari S, Leigh J, Pedley K, Nel E. Evaluation of streamlined programming procedures for the Nucleus cochlear implant with the Contour electrode array. Ear Hear. 2005 Dec;26(6):651-68. doi: 10.1097/01.aud.0000188201.86799.01.
PubMed 16378000
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Cochlear Implant MAP-parameters in Children, Reprogramming Based on Active Co-operation
- ClinicalTrials.gov ID
- NCT03694340
- Acronym / sponsor ID
- VGRFOU-247791
- Conditions
- Cochlear Implants, Evoked Potentials, Auditory, Child, Disabilities Hearing, Deafness, Hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Oct 2018 (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.
This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements.
At Sahlgrenska University Hospital in Gothenburg, generally, all younger children (0-3 years), the last ten years, had their CI's programmed based on objective measurements. The programming of the CI carried out during the first year after the surgical insertion is done on the foundation of the objective measurements and is generally what the child will live with thereafter. This method also seem to be close to other clinics in Sweden and the rest of the world, however, there are no specific guidelines regarding the how the programming of the CI is to be carried out on small children. To this date there are no studies, to our knowledge, that have confirmed the validity of using these objective measurements and if it is the best for the child. We therefore aim to do a long term follow up on children that have received CI and programmed this way, and study if there would be beneficial to redo the programming when the child is old enough to actively participate.
The aim with this project is evaluate how suitable it is to mainly use objective measurements when programming the cochlear implant and, in addition to this, examine if the children's hearing can be improved if the programming is based on the behavioral measurements of sound when the children are old enough to participate in such. It will examine what happens with the end result if the programming foundation differentiates from one another; if there are any measurable differences in hearing skills.
The result from this project expects to generate knowledge that is highly important for those working with small children receiving CI's, and by extension it will benefit the children that rely on this device in there every day life.
Detailed description
Cochlear implants (CI) enable hearing for persons who otherwise would have been deaf. A CI substitutes the sensory cells in the cochlea and stimulates the auditory nerve directly with weak electrical pulses. For children born deaf, or become deaf at an early age, prompt detection of this condition is important to since it enables the possibility of an early implantation of the CI and facilitates the child's development of a spoken language. When it comes to detecting deafness in newborns, Sweden has a well-functioning and widespread hearing screening program for infants, permitting children born deaf, or with severe hearing impairments, to be discovered very early. In general, children that are born deaf can get a CI implanted at about one year of age, if there are no other contraindications. Internationally it has become increasingly common for implants to be inserted at even lower ages, sometimes even as young as five months of age.
For small children who receive CI's at an early age it is not possible to perform measurements based on the child making subjective assessments of how the sound is perceived when the electrical stimulation is altered through the implant. Also, small children cannot judge and report back the quality of the sound. Instead, objective measurements are commonly used since they do not require the active participation of the child, along with observations of the child and how it spontaneously reacts to the sound stimulation. A common objective measurement is to find the lowest level of electrical stimulation required to obtain a response from the auditory nerve, i.e. the electrically evoked action potential (ECAP) threshold. The CI manufacturer Cochlear Ltd has developed an automatic system for this measurement. Based on such measurements, as the automatic ECAP-measurement, the electrical stimulation from the implant can adjusted to the so-called MAP, where the minimum and maximum stimulation levels (T- respectively C-levels) are set for each individual electrode on the implant to create the dynamic range of electrical stimulation. This MAP then becomes the basis for the child's ability to perceive sound.
Clinically, today (at Sahlgrenska University Hospital, Gothenburg, Sweden) a basic programming of the MAP is performed based on ECAP measurements, after which adjustment of only the overall level is carried out based on the child's reactions. However, no subjective measurement is made regarding threshold levels of stimulation through the implant or that the child actually perceives medium sound equally across the different channels. When the child can participate in sound field audiometry, adjustments of the MAP settings are made to get a straight audiogram, but basically, the children continue to use the setting based on the ECAP measurement. Adult patients with acquired deafness receiving CI are managed in a different manner than the children. The programming of the implant for adults is based on subjective measurements of how stimulation via individual electrodes is perceived. By measuring thresholds for individual electrodes, i.e. minimum audible stimulation (T-levels) and levels where stimulation is immediately below unpleasant strong (C-levels), then the MAP is programmed with an individual dynamic range for each electrode.
To our knowledge no previous study have explored how the MAP based on an ECAP measurement endures over time or if a re-programming should be carried out when the child reliably can participate in behavioral measurements, which is about seven years of age in terms of measuring T-levels. Studies have shown that there is a correlation between ECAP-thresholds and T- and C-levels for people who can participate actively. However, the relationship is relatively weak and some researchers have even considered it too weak for ECAP thresholds to be the basis for programming the implant. However, in most clinics, these thresholds are used as a basis for programming CI to small children.
Several of those who work with programming the MAP in small children claims to witness an adaptation in sensitivity of the auditory nerve to the applied stimulation; indicating that the results of the objective measurement could gradually change if there is an alternation in stimulation levels. However, there are no studies at this time that neither confirm nor deny this.
The aim of this project is to investigate and clarify how children who receive CI at an early age should be monitored and to evaluate the objective ECAP measurement as a basis for setting stimulation levels. It also aims to investigate if there is any change in the result of the ECAP measurement after adjustment has been made in the MAP. After completion of the study, the goal is to offer a better and more knowledge-based (re-) habilitation for children who receive CI's, for whom there are currently no definite guidelines for programming and follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case research design
| Arm | Type | Receives |
|---|---|---|
| Re-programming of cochlear implant | Other | Other: Re-programming of cochlear implantThe cochlear implant is programmed with a new MAP based on behavioral measurements of T- and C-levels and used by the participant for 4 months before follow up. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cochlear implant by Cochlear Ltd type: CI24RE or newer
- Received cochlear implant before three years of age
- Have carried out hearing tests with tones and speech recognition
Key exclusion criteria (1 listed)
- Malformation of the cochlea
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 |
|---|---|---|
| Re-programming of cochlear implantNew MAP based on behavioral T- and C-levels | Other | Re-programming of cochlear implant |
Primary outcome
Change in speech perception
Time frame: Performed at baseline and 4 months after intervention
Sound field hearing test performed with a pre-recorded speech material consisting of everyday sentences.
Change in tone threshold
Time frame: Performed at baseline and 4 months after intervention
Sound field hearing test performed with tones to determine hearing thresholds.
Behavioral T-thresholds
Time frame: Performed at intervention
Behavioral measurements of the T-levels that constitutes the the lower level of the dynamic range when programming the cochlear implant (setting the MAP).
Behavioral C-thresholds
Time frame: Performed at intervention
Behavioral measurements of the C-levels that constitutes the upper level of the dynamic range when programming the cochlear implant (setting the MAP).
Change in automatically recorded electrical evoked action potential thresholds
Time frame: Performed at baseline and 4 months after intervention
The measurement used for programming the cochlear implant if not behavioral measurements are feasible (e.g. small children).
1 secondary outcome
Change in results from "Children's Home Inventory for Listening Difficulties" questionnaire
Time frame: Performed at baseline and 4 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 4 Dec 2020.
- Background: PubMed 19507225Roland JT Jr, Cosetti M, Wang KH, Immerman S, Waltzman SB. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009 Nov;119(11):2205-10. doi: 10.1002/lary.20489.
- Background: PubMed 28945656de Vos JJ, Biesheuvel JD, Briaire JJ, Boot PS, van Gendt MJ, Dekkers OM, Fiocco M, Frijns JHM. Use of Electrically Evoked Compound Action Potentials for Cochlear Implant Fitting: A Systematic Review. Ear Hear. 2018 May/Jun;39(3):401-411. doi: 10.1097/AUD.0000000000000495.
- Background: PubMed 10037065Abbas PJ, Brown CJ, Shallop JK, Firszt JB, Hughes ML, Hong SH, Staller SJ. Summary of results using the nucleus CI24M implant to record the electrically evoked compound action potential. Ear Hear. 1999 Feb;20(1):45-59. doi: 10.1097/00003446-199902000-00005.
- Background: PubMed 16920343Botros A, van Dijk B, Killian M. AutoNR: an automated system that measures ECAP thresholds with the Nucleus Freedom cochlear implant via machine intelligence. Artif Intell Med. 2007 May;40(1):15-28. doi: 10.1016/j.artmed.2006.06.003. Epub 2006 Aug 22.
- Background: PubMed 16378000Plant K, Law MA, Whitford L, Knight M, Tari S, Leigh J, Pedley K, Nel E. Evaluation of streamlined programming procedures for the Nucleus cochlear implant with the Contour electrode array. Ear Hear. 2005 Dec;26(6):651-68. doi: 10.1097/01.aud.0000188201.86799.01.
- 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.
Lennart Magnusson, PhD principal investigator
Sahlgrenska University Hospital, Region Västra Götaland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-programming of cochlear implant in people with Cochlear Implants and Evoked Potentials, Auditory, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 1 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 4 Dec 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 Sweden. 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 in speech perception (time frame: Performed at baseline and 4 months after intervention). The study lists 5 primary outcomes in all. 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 NCT03694340, which also lists 5 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 4 Dec 2020.