Sensorineural Hearing LossNCT03288753
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
A study testing Satisfaction questionnaire, Speech intelligibility in quiet and Speech intelligibility in noise in people with Sensorineural Hearing Loss and Cochlear Hearing Loss, run by Oticon Medical at 9 sites in France.
Trial summary
The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- What is being tested?
- Satisfaction questionnaire, Speech intelligibility in quiet and Speech intelligibility in noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 9 sitesFrance
- Study dates
- 2 Oct 2017to 11 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- informed consent
- Native French speaker or fluent French speaker
- Patient already fitted with one or two speech processor Neuro 1 for at least 5 months
Who cannot join
- vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
- No Social security affiliation
- non-compliant patient
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital Pellegrin
Bordeaux, 33000
Hôpital Roger Salengro
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69003
CHRU de Nancy Hôpital central
Nancy, 54035
CHU de Nantes Hôtel-Dieu
Nantes, 44093
CHU Nice - Institut Universitaire de la Face et du Cou
Nice, 06103
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, 06200
Hôpital Pitié Salpêtrière - APHP
Paris, 75013
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
Official title: Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.
Read the detailed description
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries…). Some improvements available on the Neuro 2 may be particularly interesting for children.
The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.
The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).
- Conditions
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- Being tested
- Satisfaction questionnaire, Speech intelligibility in quiet, Speech intelligibility in noise, VRB (Vocale Rapide dans le Bruit)
- Keywords
- Cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction questionnaireOther
Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.
Speech intelligibility in quietBehavioural
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
Speech intelligibility in noiseBehavioural
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
VRB (Vocale Rapide dans le Bruit)Behavioural
Also called french Quick SIN
Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL.
| Study group | Role | What they receive |
|---|---|---|
| Adults and children above 14 years old | Experimental | Visit 1:
Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1
Visit 2 (15 days after V1):
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2
Visit 3 (3 months after V2):
Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2 Receives: Other: Satisfaction questionnaire; Behavioral: Speech intelligibility in quiet; Behavioral: Speech intelligibility in noise; Behavioral: VRB (Vocale Rapide dans le Bruit) |
| children up to 14 years old | Experimental | Visit 1 Satisfaction questionnaire on Neuro 1
Visit 2 (15 days after V1):
Satisfaction questionnaire on Neuro 2
Visit 3 (3 months after V2):
Satisfaction questionnaire on Neuro 2
The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions. Receives: Other: Satisfaction questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction questionnaire
The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.
Measured: 15 minutes
Secondary outcomes (3)
Speech comprehension in quiet
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
Measured: 15 mins
Speech comprehension in Noise
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
Measured: 15 mins
French Quick Sin
This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB.
Measured: 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start2 Oct 2017
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Vincent, MD, PROF, Principal investigator, Hôpital Roger Salengro CHRU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288753
- Sponsor's protocol ID
- PIC_14
- Status last verified
- Mar 2023
- First submitted
- 18 Sep 2017
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
- ClinicalTrials.gov ID
- NCT03288753
- Acronym / sponsor ID
- PIC_14
- Conditions
- Sensorineural Hearing Loss, Cochlear Hearing Loss
- Keywords
- Cochlear implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 20 Sep 2017 (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 present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.
Detailed description
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries…). Some improvements available on the Neuro 2 may be particularly interesting for children.
The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.
The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults and children above 14 years old | Experimental | Other: Satisfaction questionnaire, Behavioral: Speech intelligibility in quiet, Behavioral: Speech intelligibility in noise, Behavioral: VRB (Vocale Rapide dans le Bruit)Visit 1: Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2 |
| children up to 14 years old | Experimental | Other: Satisfaction questionnaireVisit 1 Satisfaction questionnaire on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- Native French speaker or fluent French speaker
- Patient already fitted with one or two speech processor Neuro 1 for at least 5 months
Key exclusion criteria (3 listed)
- vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
- No Social security affiliation
- non-compliant patient
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 |
|---|---|---|
| Satisfaction questionnaireParticipants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor. | Other | Adults and children above 14 years old, children up to 14 years old |
| Speech intelligibility in quietThe speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2. | Behavioural | Adults and children above 14 years old |
| Speech intelligibility in noiseThe speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2. | Behavioural | Adults and children above 14 years old |
| VRB (Vocale Rapide dans le Bruit)Also: french Quick SINSpeech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL. | Behavioural | Adults and children above 14 years old |
Primary outcome
Satisfaction questionnaire
Time frame: 15 minutes
The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.
3 secondary outcomes
Speech comprehension in quiet
Time frame: 15 mins
Speech comprehension in Noise
Time frame: 15 mins
French Quick Sin
Time frame: 5 mins
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 23 Mar 2023.
- 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.
Christophe Vincent, MD, PROF principal investigator
Hôpital Roger Salengro CHRU de Lille
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satisfaction questionnaire, Speech intelligibility in quiet and Speech intelligibility in noise in people with Sensorineural Hearing Loss and Cochlear Hearing Loss, run by Oticon Medical at 9 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 3 inclusion and 3 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Satisfaction questionnaire (time frame: 15 minutes). 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 23 Mar 2023.