Cochlear Implant ListenersNCT01284790
Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures
A study testing Cochlear implants in people with Cochlear Implant Listeners, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant Listeners
- What is being tested?
- Cochlear implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Mar 2012
- 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
- The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence).
- The adults WITH cochlear implant listeners .
Who cannot join
- Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.
Read the detailed description
This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.
- Conditions
- Cochlear Implant Listeners
- Being tested
- Cochlear implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantsDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implants | Experimental | Not described Receives: Device: Cochlear implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify waveforms aimed to improve sound perception by CI recipients
Measured: 2 YEARS
Secondary outcomes (1)
To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve.
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant ListenersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284790
- Sponsor's protocol ID
- 2010-A00439-30
- Other IDs
- 2009-35
- Status last verified
- Aug 2014
- First submitted
- 21 Jan 2011
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures
- ClinicalTrials.gov ID
- NCT01284790
- Acronym / sponsor ID
- 2010-A00439-30
- Conditions
- Cochlear Implant Listeners
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jan 2011 (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.
Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.
Detailed description
This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implants | Experimental | Device: Cochlear implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence).
- The adults WITH cochlear implant listeners .
Key exclusion criteria (1 listed)
- Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.
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 implants | Device | Cochlear implants |
Primary outcome
Identify waveforms aimed to improve sound perception by CI recipients
Time frame: 2 YEARS
1 secondary outcome
To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve.
Time frame: 2 YEARS
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
Related trials for Cochlear Implant Listeners
Not yet recruiting
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
Cochlear Implant, Cochlear Implant Users
Recruiting
Pediatric Cochlear Implant Remote Programming and Assessment
Cochlear Implant Listeners
Recruiting
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
Deafness
Not yet recruiting
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
Cochlear Hearing Loss
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.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
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 implants in people with Cochlear Implant Listeners, run by Assistance Publique Hopitaux De Marseille at 1 site 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 2 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: stopped early, as of the sponsor's last update on 1 Sep 2014. 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 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 was stopped early. Results are not available in the source record.
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?
Identify waveforms aimed to improve sound perception by CI recipients (time frame: 2 YEARS). 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 1 Sep 2014.