Paraverbal Components of Language and Cochlear Implant

NCT ID: NCT05950412

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-07-01

Brief 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 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:

1. 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

A) 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.

B) 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.

2. 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.

3. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• pulsating tinnitus
• congenital malformation of the auditory system
• history of vestibular schwannoma, active middle ear disease and complete ossification of the cochlea.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Di Nardo, Professor

Role: PRINCIPAL_INVESTIGATOR

Fondazione Universitaria Policlinico Agostino Gemelli IRCCS

Locations

Fondazione Universitaria Policlinico Agostino Gemelli IRCCS

Rome, Lazio, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Walter Di Nardo, Professor

Role: CONTACT

walter.dinardo@policlinicogemelli.it

+39 3394533003

Facility Contacts

Walter Di Nardo, Professor

Role: primary

walter.dinardo@policlinicogemelli.it

+393394533003

References

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Reference Type: RESULT

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Di 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.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Jiam 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.

Reference Type: RESULT

PMID: 28806333 (View on PubMed)

Jiam 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.

Reference Type: RESULT

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Nardo 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.

Reference Type: RESULT

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Reference Type: RESULT

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Canfarotta 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.

Reference Type: RESULT

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Di 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.

Reference Type: RESULT

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Di 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.

Reference Type: RESULT

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Di 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.

Reference Type: RESULT

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Other Identifiers

5427

Identifier Type: -

Identifier Source: org_study_id