Music Therapy After Cochlear ImplantationNCT06734897
Impact of Music Therapy on Speech Intelligibility in Noise With Cochlear Implants
A study testing music therapy after Cochlear Implantation and no music therapy after Cochlear Implantation in people with Music Therapy After Cochlear Implantation, run by Armina Kreuzer at 1 site in Switzerland.
Trial summary
The aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Music Therapy After Cochlear Implantation
- What is being tested?
- music therapy after Cochlear Implantation and no music therapy after Cochlear Implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jun 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 18-85 years
- Patients who undergo a new CI Implantation
- Patients who speak German as their main language
Who cannot join
- 1. Patients with congenital deafness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lucerne Cantonal Hospital
Lucerne, Canton of Lucerne, 6000
About this study
The aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Group A will start six months of music therapy immediately after cochlear implantation, group B six months later. A further control group 2 will not receive any music therapy. The speech intelligibility values resulting from the OLSA sentence test will be compared between the three groups after six and twelve months.
Read the 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.
- Being tested
- music therapy after Cochlear Implantation, no music therapy after Cochlear Implantation
- Keywords
- Music therapy, rehabilitation after Cochlear Implantation, Cochlear Implant, Speech Perception in Noise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapy after Cochlear ImplantationOther
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.
no music therapy after Cochlear ImplantationOther
Group C consists of persons who do not receive any music therapy after Cochlear Implantation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will begin six months of music therapy immediately after cochlear implantation. Receives: Other: music therapy after Cochlear Implantation |
| Group B | Experimental | Group B is the delayed group and will start music therapy six months after group A. Receives: Other: music therapy after Cochlear Implantation |
| Group C | Experimental | Group C won't receive any music therapy and serves as a control group. Receives: Other: no music therapy after Cochlear Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition threshold (SRT50) six month after Cochlear Implantation
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.
Measured: six month after Cochlear Implantation
Secondary outcomes (3)
values of SRT50 of group A and B at 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.
Measured: twelve months
Values of SRT50 of all groups at 12 months
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.
Measured: 12 months
subjective improvements of speech intelligibilty
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start11 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Music Therapy After Cochlear ImplantationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized study with a "start group A" and a "delayed group" B. Group A will begin six months of music therapy immediately after cochlear implantation, group B six months later. Another group consists of persons who do not receive any music therapy, will form the control group. The speech intelligibility values resulting from the OLSA sentence test are compared between the three groups after six and twelve months.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armina Kreuzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armina Kreuzer, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734897
- Sponsor's protocol ID
- Musiktherapie_Erwachsene
- Status last verified
- Jun 2025
- First submitted
- 11 Dec 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is GCP compliant.
Publications
Digeser F, Hast A, Hessel H, Hoppe U (2008): Einfluss von Obertönen auf die Frequenzdiskrimination bei Cochlear Implant Trägern
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.
PubMed 10686177Schauwecker 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.
PubMed 38353294Parbery-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.
PubMed 21589653Patel 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.
PubMed 21747773Petersen 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.
PubMed 19673820Mirza 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.
PubMed 18792140McDermott HJ. Music perception with cochlear implants: a review. Trends Amplif. 2004;8(2):49-82. doi: 10.1177/108471380400800203.
PubMed 15497033Looi 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.
PubMed 23459244Lima 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.
PubMed 30462748Hutter 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.
PubMed 27837214Hey 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.
PubMed 34401506Haumann 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.
PubMed 17136415
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music Therapy on Speech Intelligibility in Noise With Cochlear Implants
- ClinicalTrials.gov ID
- NCT06734897
- Acronym / sponsor ID
- Musiktherapie_Erwachsene
- Keywords
- Music therapy, rehabilitation after Cochlear Implantation, Cochlear Implant, Speech Perception in Noise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Armina KreuzerUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Dec 2024 (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 aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Group A will start six months of music therapy immediately after cochlear implantation, group B six months later. A further control group 2 will not receive any music therapy. The speech intelligibility values resulting from the OLSA sentence test will be compared between the three groups after six and twelve months.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized study with a "start group A" and a "delayed group" B. Group A will begin six months of music therapy immediately after cochlear implantation, group B six months later. Another group consists of persons who do not receive any music therapy, will form the control group. The speech intelligibility values resulting from the OLSA sentence test are compared between the three groups after six and twelve months.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: music therapy after Cochlear ImplantationGroup A will begin six months of music therapy immediately after cochlear implantation. |
| Group B | Experimental | Other: music therapy after Cochlear ImplantationGroup B is the delayed group and will start music therapy six months after group A. |
| Group C | Experimental | Other: no music therapy after Cochlear ImplantationGroup C won't receive any music therapy and serves as a control group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged between 18-85 years
- Patients who undergo a new CI Implantation
- Patients who speak German as their main language
Key exclusion criteria (1 listed)
- 1. Patients with congenital deafness
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 |
|---|---|---|
| music therapy after Cochlear ImplantationThe 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. | Other | Group A, Group B |
| no music therapy after Cochlear ImplantationGroup C consists of persons who do not receive any music therapy after Cochlear Implantation. | Other | Group C |
Primary outcome
Speech recognition threshold (SRT50) six month after Cochlear Implantation
Time frame: six month after Cochlear Implantation
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.
3 secondary outcomes
values of SRT50 of group A and B at twelve months
Time frame: twelve months
Values of SRT50 of all groups at 12 months
Time frame: 12 months
subjective improvements of speech intelligibilty
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- BackgroundDigeser F, Hast A, Hessel H, Hoppe U (2008): Einfluss von Obertönen auf die Frequenzdiskrimination bei Cochlear Implant Trägern
- BackgroundWagener 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.
- BackgroundWagener 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.
- Background: PubMed 10686177Schuppert 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.
- Background: PubMed 38353294Schauwecker 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.
- Background: PubMed 21589653Parbery-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.
- Background: PubMed 21747773Patel 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.
- Background: PubMed 19673820Petersen 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.
- Background: PubMed 18792140Mirza 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.
- Background: PubMed 15497033McDermott HJ. Music perception with cochlear implants: a review. Trends Amplif. 2004;8(2):49-82. doi: 10.1177/108471380400800203.
- Background: PubMed 23459244Looi 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.
- Background: PubMed 30462748Lima 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.
- PMID: 24975453Link provided by the sponsor.
- PMID: 34596714Link provided by the sponsor.
- PMID: 9201460Link provided by the sponsor.
- PMID: 34401506Link provided by the sponsor.
- PMID: 27837214Link provided by the sponsor.
- PMID: 30462748Link provided by the sponsor.
- Individual participant dataSharing planned: No. This is GCP compliant.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy after Cochlear Implantation and no music therapy after Cochlear Implantation in people with Music Therapy After Cochlear Implantation, run by Armina Kreuzer at 1 site in Switzerland.
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 1 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armina Kreuzer, Dr. tech. (+412055059, Armina.Kreuzer@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recognition threshold (SRT50) six month after Cochlear Implantation (time frame: six month after Cochlear Implantation). 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 NCT06734897, which also lists 18 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 25 Nov 2025.