Hearing Loss, SensorineuralNCT05950412
Paraverbal Components of Language and Cochlear Implant
An observational study of Hearing Loss, Sensorineural, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The investigators evaluated patients older than 6 years old, with severe hearing loss, cochlear implant wearers, able to perform a series of tests (TUISE, the pitch discrimination test, the melody discrimination test, VAS) to assess the skills of perceiving spectral components of music and understanding emotional… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Jul 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing cochlear implantation, able to understand and perform the test administered.
Who may be able to join
- patients with severe-profound sensorineural hearing loss undergoing cochlear implantation at Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy;
- Intracochlear implant placement in soft surgery technique, by mastoidectomy and posterior tympanotomy and insertion of the electrode array through the round window
- age >6 years
- patients without associated disabilities, with good auditory verbal perceptual skills and adequate language skills
- the ability to understand and perform the tests administered
Who cannot join
- pulsating tinnitus
- congenital malformation of the auditory system
- history of vestibular schwannoma, active middle ear disease and complete ossification of the cochlea.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Universitaria Policlinico Agostino Gemelli IRCCS
Rome, Lazio, 00168
Walter Di Nardo, Professor, +393394533003, walter.dinardo@policlinicogemelli.it
About this study
Official title: Relationship Between Pitch Discrimination, Music Abilities and Emotional Speech Perception in School Aged Children With Cochlear Implant
The investigators evaluated patients older than 6 years old, with severe hearing loss, cochlear implant wearers, able to perform a series of tests (TUISE, the pitch discrimination test, the melody discrimination test, VAS) to assess the skills of perceiving spectral components of music and understanding emotional states of language investigating the relationship between musical ability, pitch discrimination and paraverbal language comprehension.
Read the detailed description
The investigators evaluated patients with severe hearing loss, undergoing cochlear impantation, to assess the skills of perceiving spectral components of music and understanding emotional states of language.
Each patient will undergo:
- Music test: a battery of music tests has been designed to assess CI-mediated music perception. The software will be installed on a computer, which is normally used to adapt patients' maps in routine adaptation sessions. It consists of two parts: A) the pitch discrimination test; B) the melody discrimination test
- In the pitch discrimination test, the stimuli consist of pairs of notes played by a piano and spaced at least one semitone apart, semitone being the smallest interval in traditional Western music. The notes are distributed within the middle three octaves (C4, C5, C6, each corresponding to the following frequency bands: 262 Hz-523 Hz, 523 Hz-1046 Hz, and 1046 Hz- 1976 Hz), used for most of the pieces, for a total of 36 notes. After listening to each pair of notes, the patient is asked to indicate whether they are the same or different in pitch. It consists of seven levels of increasing difficulty determined by the reduction in the distance between notes: the 1st level included pairs of notes 12 semitones apart (easiest task), while the 7th level included notes one semitone apart (most difficult task). Each level is further divided into two tests: TEST A: consisting of two parts (each of 10 questions) in which the subject must choose between 2 notes belonging to the 5th and 6th musical octaves (523-1976 Hz). TEST B: consists of two parts (each of 10 questions) in which the subject must choose between 2 notes belonging to the 4th and 5th musical octaves (262-988 Hz). In the last 2 levels (6th and 7th levels) there are 20 more questions investigating discrimination on the middle (related to the 5th octave). At the end the score of each level will be calculated (as the percentage of correct answers) and the final total score.
- The melody discrimination test consists of 6 popular cartoon songs in digital recording, synthesized with Finale™ 2008 (MakeMusic Inc., Eden Prairie, MN). Before the test performance, subjects will be asked to watch a 30-second cartoon scene and memorize the corresponding song from an IBM© laptop (IBM, Armonk, USA). Each song will be presented twice, for a total of 12 entries. The music test is divided into two sessions: in session 1, full version songs (instrumental plus vocal) for a total of 6 voices. Patients will indicate the distinctive character on the screen for each song. In session 2, songs in melodic version, presented in random order for a total of 6 musical items. An overall score will be calculated based on the correctly identified elements.
- TUISE test (Auditory Test Identifying Emotional States): the Auditory Test of Identifying Emotional States (T.U.I.S.E.) is a new instrument to assess emotional states. It consists of 4 subtests, each consisting of 15 questions. Each item involves an audio recording of short sentences spoken with varying intonation by different readers of both sexes. To ensure proper administration, all background noise was removed and semantically neutral sentences were chosen. In addition, a glossary was developed with explanations and examples for all the emotional states presented. In the 1st subtest, the task is to identify among the four basic emotions (happy, sad, angry, scared) which one best described the speaker's emotional state (only one term, among the four words, correctly represented what the speaker was thinking or feeling). In the 2nd subtest, more complex emotions are assessed as patients have to identify among four terms regarding complex emotional states varied for each item, the one that correctly expressed the emotional state expressed by the speaker (joking, doubtful, agitated, rude, concerned, friendly, bored, excited, hopeful, surprised, overbearing and angry). In the 3rd subtest, which required speaker discrimination, each item consisted of two recordings. They are, in fact, presented with several pairs of vocal traces, and the patient has to distinguish whether each item is presented by different people or not. Finally, the 4th subtest consists to identify the gender of the speaker. Each item consists of an audio track and the patient have to mark whether the speaker is male or female.
- Visual analog scale (VAS scale): it is used to estimate, with a score from 1 to 10, how pleasant it is to listen to music.
The aim is to investigate the relationship between musical ability, pitch discrimination and paraverbal language comprehension.
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Paraverbal Components of Language and Cochlear Implant
- Medical subject headings
- Hearing Loss, Sensorineural
What is being measured
The primary outcome is the main question the study is designed to answer.
Pitch discrimination test
The stimuli consist of pairs of notes played by a piano and spaced at least one semitone apart, semitone being the smallest interval in traditional Western music. The patient is asked to indicate whether they are the same or different in pitch. It assesses discriminative skills
Measured: 6 months after cochlear implantation
Melody discrimination test
Consists of 6 popular cartoon songs in digital recording. Subjects will be asked to watch a 30-second cartoon scene and memorize the corresponding song. In session 1, full version songs (instrumental plus vocal) for a total of 6 voices. Patients will indicate the distinctive character on the screen for each song. In session 2, songs in melodic version, presented in random order for a total of 6 musical items. It assesses discriminative skills
Measured: 6 months after cochlear implantation
TUISE (Auditory Test of Identifying Emotional States)
is a new instrument to assess emotional states. It consists of 4 subtests, each consisting of 15 questions. Each item involves an audio recording of short sentences spoken with varying intonation by different readers of both sexes. To ensure proper administration, all background noise was removed and semantically neutral sentences were chosen. In addition, a glossary was developed with explanations and examples for all the emotional states presented.
Measured: 6 months after cochlear implantation
VAS
to estimate, with a score from 1 to 10, how pleasant it is to listen to music
Measured: 6 months after cochlear implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Di Nardo, Professor, Principal investigator, Fondazione Universitaria Policlinico Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950412
- Sponsor's protocol ID
- 5427
- Status last verified
- Jun 2023
- First submitted
- 10 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Issing C, Baumann U, Pantel J, Stover T. Cochlear Implant Therapy Improves the Quality of Life in Older Patients-A Prospective Evaluation Study. Otol Neurotol. 2020 Oct;41(9):1214-1221. doi: 10.1097/MAO.0000000000002741.
PubMed 32925841Di Nardo W, Anzivino R, Giannantonio S, Schinaia L, Paludetti G. The effects of cochlear implantation on quality of life in the elderly. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):65-73. doi: 10.1007/s00405-013-2396-1. Epub 2013 Feb 15.
PubMed 23411946Qazi OU, van Dijk B, Moonen M, Wouters J. Understanding the effect of noise on electrical stimulation sequences in cochlear implants and its impact on speech intelligibility. Hear Res. 2013 May;299:79-87. doi: 10.1016/j.heares.2013.01.018. Epub 2013 Feb 8.
PubMed 23396271Kressner AA, May T, Dau T. Effect of Noise Reduction Gain Errors on Simulated Cochlear Implant Speech Intelligibility. Trends Hear. 2019 Jan-Dec;23:2331216519825930. doi: 10.1177/2331216519825930.
PubMed 30755108Jiam NT, Caldwell MT, Limb CJ. What Does Music Sound Like for a Cochlear Implant User? Otol Neurotol. 2017 Sep;38(8):e240-e247. doi: 10.1097/MAO.0000000000001448.
PubMed 28806333Jiam NT, Limb CJ. Rhythm processing in cochlear implant-mediated music perception. Ann N Y Acad Sci. 2019 Oct;1453(1):22-28. doi: 10.1111/nyas.14130. Epub 2019 Jun 6.
PubMed 31168793Nardo WD, Cantore I, Cianfrone F, Melillo P, Fetoni AR, Paludetti G. Differences between electrode-assigned frequencies and cochlear implant recipient pitch perception. Acta Otolaryngol. 2007 Apr;127(4):370-7. doi: 10.1080/00016480601158765.
PubMed 17453456Vermeire K, Landsberger DM, Van de Heyning PH, Voormolen M, Kleine Punte A, Schatzer R, Zierhofer C. Frequency-place map for electrical stimulation in cochlear implants: Change over time. Hear Res. 2015 Aug;326:8-14. doi: 10.1016/j.heares.2015.03.011. Epub 2015 Apr 1.
PubMed 25840373Canfarotta MW, Dillon MT, Buss E, Pillsbury HC, Brown KD, O'Connell BP. Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients. Ear Hear. 2020 Sep/Oct;41(5):1349-1361. doi: 10.1097/AUD.0000000000000864.
PubMed 32205726Di Nardo W, Scorpecci A, Giannantonio S, Cianfrone F, Parrilla C, Paludetti G. Cochlear implant patients' speech understanding in background noise: effect of mismatch between electrode assigned frequencies and perceived pitch. J Laryngol Otol. 2010 Aug;124(8):828-34. doi: 10.1017/S0022215110000320. Epub 2010 Mar 5.
PubMed 20202276Di Nardo W, Scorpecci A, Giannantonio S, Cianfrone F, Paludetti G. Improving melody recognition in cochlear implant recipients through individualized frequency map fitting. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):27-39. doi: 10.1007/s00405-010-1335-7. Epub 2010 Jul 16.
PubMed 20635091Di Nardo W, Schinaia L, Anzivino R, De Corso E, Ciacciarelli A, Paludetti G. Musical training software for children with cochlear implants. Acta Otorhinolaryngol Ital. 2015 Oct;35(4):249-57.
PubMed 26824211
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pitch Discrimination, Music Abilities and Emotional Speech Perception in School Aged Children With Cochlear Implant
- ClinicalTrials.gov ID
- NCT05950412
- Acronym / sponsor ID
- 5427
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Paraverbal Components of Language and Cochlear Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Jul 2023 (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 investigators evaluated patients older than 6 years old, with severe hearing loss, cochlear implant wearers, able to perform a series of tests (TUISE, the pitch discrimination test, the melody discrimination test, VAS) to assess the skills of perceiving spectral components of music and understanding emotional states of language investigating the relationship between musical ability, pitch discrimination and paraverbal language comprehension.
Detailed description
The investigators evaluated patients with severe hearing loss, undergoing cochlear impantation, to assess the skills of perceiving spectral components of music and understanding emotional states of language.
Each patient will undergo:
- Music test: a battery of music tests has been designed to assess CI-mediated music perception. The software will be installed on a computer, which is normally used to adapt patients' maps in routine adaptation sessions. It consists of two parts: A) the pitch discrimination test; B) the melody discrimination test
- In the pitch discrimination test, the stimuli consist of pairs of notes played by a piano and spaced at least one semitone apart, semitone being the smallest interval in traditional Western music. The notes are distributed within the middle three octaves (C4, C5, C6, each corresponding to the following frequency bands: 262 Hz-523 Hz, 523 Hz-1046 Hz, and 1046 Hz- 1976 Hz), used for most of the pieces, for a total of 36 notes. After listening to each pair of notes, the patient is asked to indicate whether they are the same or different in pitch. It consists of seven levels of increasing difficulty determined by the reduction in the distance between notes: the 1st level included pairs of notes 12 semitones apart (easiest task), while the 7th level included notes one semitone apart (most difficult task). Each level is further divided into two tests: TEST A: consisting of two parts (each of 10 questions) in which the subject must choose between 2 notes belonging to the 5th and 6th musical octaves (523-1976 Hz). TEST B: consists of two parts (each of 10 questions) in which the subject must choose between 2 notes belonging to the 4th and 5th musical octaves (262-988 Hz). In the last 2 levels (6th and 7th levels) there are 20 more questions investigating discrimination on the middle (related to the 5th octave). At the end the score of each level will be calculated (as the percentage of correct answers) and the final total score.
- The melody discrimination test consists of 6 popular cartoon songs in digital recording, synthesized with Finale™ 2008 (MakeMusic Inc., Eden Prairie, MN). Before the test performance, subjects will be asked to watch a 30-second cartoon scene and memorize the corresponding song from an IBM© laptop (IBM, Armonk, USA). Each song will be presented twice, for a total of 12 entries. The music test is divided into two sessions: in session 1, full version songs (instrumental plus vocal) for a total of 6 voices. Patients will indicate the distinctive character on the screen for each song. In session 2, songs in melodic version, presented in random order for a total of 6 musical items. An overall score will be calculated based on the correctly identified elements.
- TUISE test (Auditory Test Identifying Emotional States): the Auditory Test of Identifying Emotional States (T.U.I.S.E.) is a new instrument to assess emotional states. It consists of 4 subtests, each consisting of 15 questions. Each item involves an audio recording of short sentences spoken with varying intonation by different readers of both sexes. To ensure proper administration, all background noise was removed and semantically neutral sentences were chosen. In addition, a glossary was developed with explanations and examples for all the emotional states presented. In the 1st subtest, the task is to identify among the four basic emotions (happy, sad, angry, scared) which one best described the speaker's emotional state (only one term, among the four words, correctly represented what the speaker was thinking or feeling). In the 2nd subtest, more complex emotions are assessed as patients have to identify among four terms regarding complex emotional states varied for each item, the one that correctly expressed the emotional state expressed by the speaker (joking, doubtful, agitated, rude, concerned, friendly, bored, excited, hopeful, surprised, overbearing and angry). In the 3rd subtest, which required speaker discrimination, each item consisted of two recordings. They are, in fact, presented with several pairs of vocal traces, and the patient has to distinguish whether each item is presented by different people or not. Finally, the 4th subtest consists to identify the gender of the speaker. Each item consists of an audio track and the patient have to mark whether the speaker is male or female.
- Visual analog scale (VAS scale): it is used to estimate, with a score from 1 to 10, how pleasant it is to listen to music.
The aim is to investigate the relationship between musical ability, pitch discrimination and paraverbal language comprehension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing cochlear implantation, able to understand and perform the test administered.
Key inclusion criteria (5 listed)
- patients with severe-profound sensorineural hearing loss undergoing cochlear implantation at Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy;
- Intracochlear implant placement in soft surgery technique, by mastoidectomy and posterior tympanotomy and insertion of the electrode array through the round window
- age >6 years
- patients without associated disabilities, with good auditory verbal perceptual skills and adequate language skills
- the ability to understand and perform the tests administered
Key exclusion criteria (3 listed)
- pulsating tinnitus
- congenital malformation of the auditory system
- history of vestibular schwannoma, active middle ear disease and complete ossification 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.
Primary outcome
Pitch discrimination test
Time frame: 6 months after cochlear implantation
The stimuli consist of pairs of notes played by a piano and spaced at least one semitone apart, semitone being the smallest interval in traditional Western music. The patient is asked to indicate whether they are the same or different in pitch. It assesses discriminative skills
Melody discrimination test
Time frame: 6 months after cochlear implantation
Consists of 6 popular cartoon songs in digital recording. Subjects will be asked to watch a 30-second cartoon scene and memorize the corresponding song. In session 1, full version songs (instrumental plus vocal) for a total of 6 voices. Patients will indicate the distinctive character on the screen for each song. In session 2, songs in melodic version, presented in random order for a total of 6 musical items. It assesses discriminative skills
TUISE (Auditory Test of Identifying Emotional States)
Time frame: 6 months after cochlear implantation
is a new instrument to assess emotional states. It consists of 4 subtests, each consisting of 15 questions. Each item involves an audio recording of short sentences spoken with varying intonation by different readers of both sexes. To ensure proper administration, all background noise was removed and semantically neutral sentences were chosen. In addition, a glossary was developed with explanations and examples for all the emotional states presented.
VAS
Time frame: 6 months after cochlear implantation
to estimate, with a score from 1 to 10, how pleasant it is to listen to music
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 32925841Issing C, Baumann U, Pantel J, Stover T. Cochlear Implant Therapy Improves the Quality of Life in Older Patients-A Prospective Evaluation Study. Otol Neurotol. 2020 Oct;41(9):1214-1221. doi: 10.1097/MAO.0000000000002741.
- Results publication: PubMed 23411946Di Nardo W, Anzivino R, Giannantonio S, Schinaia L, Paludetti G. The effects of cochlear implantation on quality of life in the elderly. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):65-73. doi: 10.1007/s00405-013-2396-1. Epub 2013 Feb 15.
- Results publication: PubMed 23396271Qazi OU, van Dijk B, Moonen M, Wouters J. Understanding the effect of noise on electrical stimulation sequences in cochlear implants and its impact on speech intelligibility. Hear Res. 2013 May;299:79-87. doi: 10.1016/j.heares.2013.01.018. Epub 2013 Feb 8.
- Results publication: PubMed 30755108Kressner AA, May T, Dau T. Effect of Noise Reduction Gain Errors on Simulated Cochlear Implant Speech Intelligibility. Trends Hear. 2019 Jan-Dec;23:2331216519825930. doi: 10.1177/2331216519825930.
- Results publication: PubMed 28806333Jiam NT, Caldwell MT, Limb CJ. What Does Music Sound Like for a Cochlear Implant User? Otol Neurotol. 2017 Sep;38(8):e240-e247. doi: 10.1097/MAO.0000000000001448.
- Results publication: PubMed 31168793Jiam NT, Limb CJ. Rhythm processing in cochlear implant-mediated music perception. Ann N Y Acad Sci. 2019 Oct;1453(1):22-28. doi: 10.1111/nyas.14130. Epub 2019 Jun 6.
- Results publication: PubMed 17453456Nardo WD, Cantore I, Cianfrone F, Melillo P, Fetoni AR, Paludetti G. Differences between electrode-assigned frequencies and cochlear implant recipient pitch perception. Acta Otolaryngol. 2007 Apr;127(4):370-7. doi: 10.1080/00016480601158765.
- Results publication: PubMed 25840373Vermeire K, Landsberger DM, Van de Heyning PH, Voormolen M, Kleine Punte A, Schatzer R, Zierhofer C. Frequency-place map for electrical stimulation in cochlear implants: Change over time. Hear Res. 2015 Aug;326:8-14. doi: 10.1016/j.heares.2015.03.011. Epub 2015 Apr 1.
- Results publication: PubMed 32205726Canfarotta MW, Dillon MT, Buss E, Pillsbury HC, Brown KD, O'Connell BP. Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients. Ear Hear. 2020 Sep/Oct;41(5):1349-1361. doi: 10.1097/AUD.0000000000000864.
- Results publication: PubMed 20202276Di Nardo W, Scorpecci A, Giannantonio S, Cianfrone F, Parrilla C, Paludetti G. Cochlear implant patients' speech understanding in background noise: effect of mismatch between electrode assigned frequencies and perceived pitch. J Laryngol Otol. 2010 Aug;124(8):828-34. doi: 10.1017/S0022215110000320. Epub 2010 Mar 5.
- Results publication: PubMed 20635091Di Nardo W, Scorpecci A, Giannantonio S, Cianfrone F, Paludetti G. Improving melody recognition in cochlear implant recipients through individualized frequency map fitting. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):27-39. doi: 10.1007/s00405-010-1335-7. Epub 2010 Jul 16.
- Results publication: PubMed 26824211Di Nardo W, Schinaia L, Anzivino R, De Corso E, Ciacciarelli A, Paludetti G. Musical training software for children with cochlear implants. Acta Otorhinolaryngol Ital. 2015 Oct;35(4):249-57.
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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.
Walter Di Nardo, Professor principal investigator
Fondazione Universitaria Policlinico Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walter Di Nardo, Professor (+39 3394533003, walter.dinardo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pitch discrimination test (time frame: 6 months after cochlear implantation). The study lists 4 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 NCT05950412, which also lists 12 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 24 Jul 2023.