Clinical trial NCT05950412: Paraverbal Components of Language and Cochlear Implant
Official title: Relationship Between Pitch Discrimination, Music Abilities and Emotional Speech Perception in School Aged Children With Cochlear Implant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Sensorineural
Keywords: Paraverbal Components of Language and Cochlear Implant
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cochlear implantation, able to understand and perform the test administered.

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.

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.

Primary outcomes:
measure: Pitch discrimination test
timeFrame: 6 months after cochlear implantation
measure: Melody discrimination test
timeFrame: 6 months after cochlear implantation
measure: TUISE (Auditory Test of Identifying Emotional States)
timeFrame: 6 months after cochlear implantation
measure: VAS
timeFrame: 6 months after cochlear implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Universitaria Policlinico Agostino Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Universitaria Policlinico Agostino Gemelli IRCCS
name: Walter Di Nardo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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