- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06734897
Impact of Music Therapy on Speech Intelligibility in Noise With Cochlear Implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Improved speech perception is a main objective for any hearing rehabilitation using hearing devices. Even more challenging is speech comprehension in noisy environments.
Music therapy is one of the approaches that can assist users with achieving better performance in situations of difficult listening comprehension such as speech perception in noisy environments. One such music therapy concept developed in Heidelberg is based on the parallelism of language and music, whereby targeted training using musical parameters such as rhythm, pitch and timbre can have an impact on the ability to perceive speech. At present, the fact that music therapy can help improve speech intelligibility is primarily based on research with normal hearing listeners.
Nowadays, cochlear implant technology has the primary goal to restore functional hearing and speech perception in people with bilateral severe-to-profound sensorineural hearing loss. Good results will be achieved by post lingually deafened CI users regarding the understanding of open-set sentences presented in quiet. But our surroundings are rarely quiet. Therefore, the goal of good rehabilitation must be to ensure that CI users also can cope well in our noisy environment. Music therapy is thus intended to be the crucial piece in the puzzle that enables such understanding in noisy situations.
This study aims to investigate the benefits of music therapy for cochlear implant users in terms of their speech intelligibility performance in noise. This is an explorative study to determine suitable parameters such as the time point of starting the music.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Armina Kreuzer, Dr. tech.
- Phone Number: +412055059
- Email: Armina.Kreuzer@luks.ch
Study Locations
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Canton of Lucerne
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Lucerne, Canton of Lucerne, Switzerland, 6000
- Recruiting
- Lucerne Cantonal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient aged between 18-85 years
- Patients who undergo a new CI Implantation
- Patients who speak German as their main language
Exclusion Criteria:
1. Patients with congenital deafness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
Group A will begin six months of music therapy immediately after cochlear implantation.
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The music therapy is specially designed for the rehabilitation of CI-patients.
It focuses on learning to distinguish different sound sources, especially when they occur at the same time.
Training involves familiarization with different aspects of music such as rhythm, melody, and pitch while at the same time also getting to know the sound of different musical instruments, including singing.
The training is also aimed at learning to concentrate on spoken instructions while the music is going on.
This latter aim is fundamental to the goal of this study and plays a central role in the therapy.
|
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Experimental: Group B
Group B is the delayed group and will start music therapy six months after group A.
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The music therapy is specially designed for the rehabilitation of CI-patients.
It focuses on learning to distinguish different sound sources, especially when they occur at the same time.
Training involves familiarization with different aspects of music such as rhythm, melody, and pitch while at the same time also getting to know the sound of different musical instruments, including singing.
The training is also aimed at learning to concentrate on spoken instructions while the music is going on.
This latter aim is fundamental to the goal of this study and plays a central role in the therapy.
|
|
Experimental: Group C
Group C won't receive any music therapy and serves as a control group.
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Group C consists of persons who do not receive any music therapy after Cochlear Implantation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech recognition threshold (SRT50) six month after Cochlear Implantation
Time Frame: six month after Cochlear Implantation
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The variable of primary interest is the speech recognition threshold (SRT50), measured in dB SNR (Signal-to-Noise Ratio), which leads to 50% speech understanding, as obtained using the OLSA-test following six months of music therapy immediately after implantation.
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six month after Cochlear Implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
values of SRT50 of group A and B at twelve months
Time Frame: twelve months
|
The question should be clarified as to whether the two groups A and B demonstrate the same improvement after 1 year.
The values of the SRT50 of both groups will be compared at twelve months.
The results could provide information on whether it makes a difference whether therapy is started immediately after the operation or only after six months.
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twelve months
|
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Values of SRT50 of all groups at 12 months
Time Frame: 12 months
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It is also of interest whether the values of the SRT50 at twelve months of group C are really significantly different compared to A and B. This will give us an overview regarding the general benefits of music therapy for speech intelligibility in noise for CI users.
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12 months
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subjective improvements of speech intelligibilty
Time Frame: 6 and 12 months
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Subjective improvements in speech intelligibility after music therapy is determined using the HISQUI (Hearing Implant Sound Quality Index) questionnaire.
This is a validated questionnaire consisting of 19 items scored on a 7-point Likert scale, for quantifying the self-perceived level of auditory benefit that cochlear implant users experience in everyday listening situations.
A total of between 19 and 133 points can be achieved, and, depending on the result, 5 subjective sound quality categories are determined.
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6 and 12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Looi V, Gfeller K, Driscoll V. MUSIC APPRECIATION AND TRAINING FOR COCHLEAR IMPLANT RECIPIENTS: A REVIEW. Semin Hear. 2012 Nov 1;33(4):307-334. doi: 10.1055/s-0032-1329222. Epub 2012 Nov 19.
- Patel AD. Why would Musical Training Benefit the Neural Encoding of Speech? The OPERA Hypothesis. Front Psychol. 2011 Jun 29;2:142. doi: 10.3389/fpsyg.2011.00142. eCollection 2011.
- Wagener KC, Kühnel V, Kollmeier B (1999b) Entwicklung und Evaluation eines Satztests für die deutsche Sprache III: Evaluation des Oldenburger Sprachtests. Z Audiol 38:86-95.
- Wagener KC, Kühnel V, Kollmeier B (1999a) Entwicklung und Evaluation eines Satztests für die deutsche Sprache I: Design des Oldenburger Satztests. Z Audiol 38:4-15.
- Schuppert M, Munte TF, Wieringa BM, Altenmuller E. Receptive amusia: evidence for cross-hemispheric neural networks underlying music processing strategies. Brain. 2000 Mar;123 Pt 3:546-59. doi: 10.1093/brain/123.3.546.
- Schauwecker N, Patro A, Holder JT, Bennett ML, Perkins E, Moberly AC. Cochlear Implant Qualification in Noise Versus Quiet: Do Patients Demonstrate Similar Postoperative Benefits? Otolaryngol Head Neck Surg. 2024 May;170(5):1411-1420. doi: 10.1002/ohn.677. Epub 2024 Feb 14.
- Parbery-Clark A, Strait DL, Anderson S, Hittner E, Kraus N. Musical experience and the aging auditory system: implications for cognitive abilities and hearing speech in noise. PLoS One. 2011 May 11;6(5):e18082. doi: 10.1371/journal.pone.0018082.
- Petersen B, Mortensen MV, Gjedde A, Vuust P. Reestablishing speech understanding through musical ear training after cochlear implantation: a study of the potential cortical plasticity in the brain. Ann N Y Acad Sci. 2009 Jul;1169:437-40. doi: 10.1111/j.1749-6632.2009.04796.x.
- Mirza S, Douglas SA, Lindsey P, Hildreth T, Hawthorne M. Appreciation of music in adult patients with cochlear implants: a patient questionnaire. Cochlear Implants Int. 2003 Jun;4(2):85-95. doi: 10.1179/cim.2003.4.2.85.
- McDermott HJ. Music perception with cochlear implants: a review. Trends Amplif. 2004;8(2):49-82. doi: 10.1177/108471380400800203.
- Lima JP, Iervolino SMS, Schochat E. Musical and temporal auditory skills in cochlear implant users after music therapy. Codas. 2018 Nov 12;30(6):e20180006. doi: 10.1590/2317-1782/20182018006. English, Portuguese.
- Hutter E, Grapp M, Argstatter H. [Music therapy in adults with cochlear implants : Effects on music perception and subjective sound quality]. HNO. 2016 Dec;64(12):880-890. doi: 10.1007/s00106-016-0279-7. German.
- Hey M, Bohnke B, Mewes A, Munder P, Mauger SJ, Hocke T. Speech comprehension across multiple CI processor generations: Scene dependent signal processing. Laryngoscope Investig Otolaryngol. 2021 Jun 15;6(4):807-815. doi: 10.1002/lio2.564. eCollection 2021 Aug.
- Haumann S, Muhler R, Ziese M, von Specht H. [Discrimination of musical pitch with cochlear implants]. HNO. 2007 Aug;55(8):613-9. doi: 10.1007/s00106-006-1485-5. German.
- Gfeller K, Woodworth G, Robin DA, Witt S, Knutson JF. Perception of rhythmic and sequential pitch patterns by normally hearing adults and adult cochlear implant users. Ear Hear. 1997 Jun;18(3):252-60. doi: 10.1097/00003446-199706000-00008.
- Dincer D'Alessandro H, Boyle PJ, Portanova G, Mancini P. Music perception and speech intelligibility in noise performance by Italian-speaking cochlear implant users. Eur Arch Otorhinolaryngol. 2022 Aug;279(8):3821-3829. doi: 10.1007/s00405-021-07103-x. Epub 2021 Oct 1.
- Amann E, Anderson I. Development and validation of a questionnaire for hearing implant users to self-assess their auditory abilities in everyday communication situations: the Hearing Implant Sound Quality Index (HISQUI19). Acta Otolaryngol. 2014 Sep;134(9):915-23. doi: 10.3109/00016489.2014.909604. Epub 2014 Jun 30.
- Digeser F, Hast A, Hessel H, Hoppe U (2008): Einfluss von Obertönen auf die Frequenzdiskrimination bei Cochlear Implant Trägern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Musiktherapie_Erwachsene
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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