Hearing LossNeurAttContrNCT05513352
Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
A study testing tACS - transcranial alternating current stimulation and NF - Neurofeedback in people with Hearing Loss and Attention Impaired, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study will improve the understanding of the cerebral mechanisms that underlie the control of auditory selective attention and evaluate the potential of neuromodulation to enhance neural attention control as a possible way to overcome hearing impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Attention Impaired, Tinnitus
- What is being tested?
- tACS - transcranial alternating current stimulation and NF - Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2023to Apr 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-35 / 55-75
- German as first language
- Normal or corrected to normal vision
- Right-handed
- Normal hearing, hearing impairment or tinnitus (see specified inclusion)
- Normal hearing: ≤20 decibel (dB) hearing level (HL) at frequencies from 250 Hz to 8,000 Hz for both ears.
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- Specified inclusion for Experiment 1, 2, 3 \& 4:
- Hearing loss:
- bilateral symmetrical sensorineural hearing loss
- pure tone thresholds of ≥25 dB HL at one or more frequencies between 250 Hz and 8,000 Hz and differences in thresholds across the two ears of ≤20 dB at every frequency.
- Tinnitus:
- Persistent chronic tinnitus with duration of more than 3 months
- Tinnitus with a Tinnitus Handicap Inventory Grade 2 to 4 (18-76 points)
Who cannot join
- Non-symmetrical hearing loss
- Raised bi- or multilingually (second language acquired earlier than 6 years of age)
- Women who are currently pregnant or breastfeeding
- History of brain injury or any neurological disorder (y/n)
- For example, stroke, traumatic brain injury, brain surgery, epilepsy etc.
- Dyslexia
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- History of psychiatric disorder
- Recent recreational drug consumption
- Known or suspected drug or alcohol abuse
- Medication with cognitive side effects (e.g., psychoactive medications or sleeping pills)
- Metallic implants in the head region (excluding fixed braces and tooth fillings)
- Any implanted medical device (e.g., cardiac pacemakers)
- Previous enrolment in one of the experiments comprising the main investigational plan
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich, 8090
Basil Preisig, Dr., basil.preisig@uzh.ch
Nataliya Fartdinova, MA, nataliya.fartdinova@uzh.ch
About this study
This study will improve the understanding of the cerebral mechanisms that underlie the control of auditory selective attention and evaluate the potential of neuromodulation to enhance neural attention control as a possible way to overcome hearing impairment.
First, electroencephalography (EEG) will be applied to identify neural marker of auditory attention in individuals with hearing loss (HL), tinnitus (TI) and normal hearing (NH). Afterwards, the importance of the identified markers for attention control will be tested using non-invasive transcranial alternating current stimulation (tACS) and neurofeedback (NF).
Read the detailed description
Hearing loss and associated conditions such as tinnitus are the fourth highest cause of disability worldwide, with estimated annual cost of over 750 billion dollars. Due to the rise and ageing of the global population, the number of people with hearing impairment is growing at a rapid pace. Besides, the incidence of noise induced hearing impairment is also increasing in younger populations. A common complaint of hearing impaired individuals is the significant decline of speech comprehension under challenging listening conditions. These situations typically include reverberations, background noise or multiple speakers and they require the listener to direct attention selectively to a target sound source (e.g. the interlocutor) and to suppress distracting sounds in the background (e.g. from not attended speakers).
Auditory prostheses with pinna-imitating microphones can improve the localization of a target sound source through the sensory enhancement of spatial cues in the acoustic signal. However, the benefit of additional sensory information is limited due of the missing implementation of attention control that would permit the selective amplification of the target sound source and the suppression of irrelevant distracting noise.
The question of how the brain instantiates attentional filter mechanisms that control target amplification and distractor suppression has drawn a lot of interest in the field of cognitive neuroscience. Neural markers of auditory attention such as lateralized oscillatory brain activity in the alpha frequency band (~8-12Hz) and the enhanced neural tracking of attended of attended speech have been linked to the top-down control of attention. However, the interrelationship between these neural markers is still underexplored. Further, the functional role of alpha band oscillations in auditory attention is underspecified as they could potentially implement target enhancement and distractor suppression. Together, this limits the understanding of the neuro-cognitive basis of attention.
The proposed project aims to address this problem by improving the investigators understanding of the cerebral mechanisms that underlie the control of auditory selective attention. The outlined research project will test the hypothesis that individuals with hearing impairment have deficits in auditory distractor inhibition that are reflected by ineffective neural suppression of irrelevant information. This hypothesis will be examined in three different lines of research. In research line 1, I will test a new framework in individuals who suffer from sensorineural hearing loss or tinnitus that allows to dissociate target selection and distractor suppression at the neural level based on electroencephalography (EEG) recordings. In research lines 2-3, I will then evaluate the potential of electric brain stimulation and neurofeedback to enhance auditory distractor suppression.The results of this project will have theoretical implications for current models of auditory attention and speech comprehension by specifying the functional role of oscillatory brain activity in normal hearing individual and hearing impaired populations. Beyond, this research will contribute new insights how the control of auditory selective attention could be implemented in a brain-computer interface.
- Conditions
- Hearing Loss, Attention Impaired, Tinnitus
- Being tested
- tACS - transcranial alternating current stimulation, sham - transcranial alternating current stimulation, NF - Neurofeedback
- Keywords
- neuromodulation, auditory attention, neurobiology of language, electroencephalography, transcranial alternating current stimulation, neurofeedback, alpha oscillations, speech tracking
- Medical subject headings
- Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS - transcranial alternating current stimulationDevice
TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.
The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.
sham - transcranial alternating current stimulationDevice
During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.
The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.
NF - NeurofeedbackDevice
Neurofeedback (NF) is a non-invasive approach that combines neurophysiological recordings with real-time sensory feedback (most studies use visual feedback). Through real-time NF, individuals thus can learn to regulate their brain activity.
In this study, NF will be based on concurrent EEG recordings. During NF, participants will observe a space ship automatically navigating through a narrow tunnel. The modulation of their neural alpha power lateralization into the trained direction will be rewarded by the acceleration of the space ship, a modulation in the opposite direction will reduce speed and autopilot accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1 - Normal hearing - AAT | No intervention | Each participant assigned to the normal hearing group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT). |
| Experiment 1 - Hearing impaired - AAT | No intervention | Each participant assigned to the normal hearing impaired group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT). |
| Experiment 2 - normal hearing _ SAT | No intervention | Each participant assigned to the normal hearing group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 2 - hearing impaired - SAT | No intervention | Each participant assigned to the hearing impaired group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 2 - tinnitus - SAT | No intervention | Each participant assigned to the tinnitus group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 3 - normal hearing (tACS) - AAT | Experimental | The subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 3 - normal hearing (sham) - AAT | Sham comparator | The subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 3 - hearing impaired (tACS) - AAT | Experimental | The subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 3 - hearing impaired (sham) - AAT | Sham comparator | The subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 3 - tinnitus (tACS) - AAT | Experimental | The subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 3 - tinnitus (sham) - AAT | Sham comparator | The subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 4 - normal hearing (tACS) - SAT | Experimental | The subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 4 - normal hearing (sham) - SAT | Sham comparator | The subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 4 - hearing impaired (tACS) - SAT | Experimental | The subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 4 - hearing impaired (sham) - SAT | Sham comparator | The subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 4 - tinnitus (tACS) - SAT | Experimental | The subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: tACS - transcranial alternating current stimulation |
| Experiment 4 - tinnitus (sham) - SAT | Sham comparator | The subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex.
Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. Receives: Device: sham - transcranial alternating current stimulation |
| Experiment 5 - normal hearing (NF right) - AAT | Experimental | Each participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the right relative to the left parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded. Receives: Device: NF - Neurofeedback |
| Experiment 5 - normal hearing (NF left) - AAT | Active comparator | Each participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the left relative to the right parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded. Receives: Device: NF - Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiment 1 - EEG
The primary endpoint is the comparison of neural alpha power lateralization in response to target selection and distractor suppression in individuals with HL, TI and a NH control group.
Measured: One study session of 4 hours and 40 minutes
Experiment 2 - EEG
The primary endpoint is the comparison of the neural tracking of the amplitude envelope of speech between individuals with HL, TI and NH.
Measured: One study session of 4 hours and 40 minutes
Experiment 3 - AAT
The primary endpoint is the comparison of auditory attention performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Measured: One study session of 4 hours and 40 minutes
Experiment 4 - SAT
The primary endpoint is the comparison of speech comprehension performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Measured: One study session of 4 hours and 40 minutes
Experiment 5 - EEG 1
The primary endpoint is the comparison of participants' ability to control alpha power lateralization index during training between training conditions (left NF training vs. right NF training).
Measured: two sessions of 4 hours and 40 minutes on separate days
Secondary outcomes (9)
Experiment 1 - AAT
To test whether alpha power lateralization during distractor suppression and target selection predicts AAT task performance in HL, TI, and NH individuals.
Measured: One study session of 4 hours and 40 minutes
Experiment 2 - SAT
The relation between neural speech tracking and speech comprehension performance in NH, HL, and TI
Measured: One study session of 4 hours and 40 minutes
Experiment 3 - EEG 1
Comparison of neural alpha power lateralization between stimulation conditions (tACS vs. sham)
Measured: One study session of 4 hours and 40 minutes
Experiment 3 - EEG 2
Comparison of event-related responses to target and distractor stimuli between stimulation conditions (tACS vs. sham)
Measured: One study session of 4 hours and 40 minutes
Experiment 4 - EEG 1
Comparison of lateralization index between stimulation conditions (tACS vs. sham)
Measured: One study session of 4 hours and 40 minutes
Experiment 4 - EEG 2
Comparison between neural tracking of target and distracting speech between stimulation conditions (tACS vs. sham)
Measured: One study session of 4 hours and 40 minutes
Experiment 5 - EEG 2
Comparison of auditory evoked responses to probes presented ipsilateral vs. contralateral to the trained hemisphere
Measured: two sessions of 4 hours and 40 minutes on separate days
Experiment 5 - EEG 3
Comparison of changes in target and distractor related alpha power lateralization between NF training conditions (left NF training vs. right NF training) pre- vs post NF Training
Measured: two sessions of 4 hours and 40 minutes on separate days
Experiment 5 - AAT
Comparison of auditory attention performance across training conditions (left NF training vs. right NF training)
Measured: two sessions of 4 hours and 40 minutes on separate days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Nov 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experiment 1: * between-subject design * 3x4 = 3(hearing group) x 4(condition) * Masking: Single (Participant) * Masking Description: single-blind Experiment 2: * between-subject design * 3x4 = 3(hearing group) x 4(condition) * Masking: Single (Participant) * Masking Description: single-blind Experiment 3: * between-subject design * 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Experiment 4: * between-subject design * 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Experiment 5: * within-subject design * 2x2x4 = 2 (training) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Primary Purpose: Basic Science
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Sponsor
- Investigators
- Basil Preisig, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513352
- Sponsor's protocol ID
- AuditoryAttention
- Other IDs
- 201864
- Acronym
- NeurAttContr
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators intend to share the raw data of the included participants and the analysis code.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
- ClinicalTrials.gov ID
- NCT05513352
- Acronym / sponsor ID
- NeurAttContr / AuditoryAttention
- Conditions
- Hearing Loss, Attention Impaired, Tinnitus
- Keywords
- neuromodulation, auditory attention, neurobiology of language, electroencephalography, transcranial alternating current stimulation, neurofeedback, alpha oscillations, speech tracking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Aug 2022 (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.
This study will improve the understanding of the cerebral mechanisms that underlie the control of auditory selective attention and evaluate the potential of neuromodulation to enhance neural attention control as a possible way to overcome hearing impairment.
First, electroencephalography (EEG) will be applied to identify neural marker of auditory attention in individuals with hearing loss (HL), tinnitus (TI) and normal hearing (NH). Afterwards, the importance of the identified markers for attention control will be tested using non-invasive transcranial alternating current stimulation (tACS) and neurofeedback (NF).
Detailed description
Hearing loss and associated conditions such as tinnitus are the fourth highest cause of disability worldwide, with estimated annual cost of over 750 billion dollars. Due to the rise and ageing of the global population, the number of people with hearing impairment is growing at a rapid pace. Besides, the incidence of noise induced hearing impairment is also increasing in younger populations. A common complaint of hearing impaired individuals is the significant decline of speech comprehension under challenging listening conditions. These situations typically include reverberations, background noise or multiple speakers and they require the listener to direct attention selectively to a target sound source (e.g. the interlocutor) and to suppress distracting sounds in the background (e.g. from not attended speakers).
Auditory prostheses with pinna-imitating microphones can improve the localization of a target sound source through the sensory enhancement of spatial cues in the acoustic signal. However, the benefit of additional sensory information is limited due of the missing implementation of attention control that would permit the selective amplification of the target sound source and the suppression of irrelevant distracting noise.
The question of how the brain instantiates attentional filter mechanisms that control target amplification and distractor suppression has drawn a lot of interest in the field of cognitive neuroscience. Neural markers of auditory attention such as lateralized oscillatory brain activity in the alpha frequency band (~8-12Hz) and the enhanced neural tracking of attended of attended speech have been linked to the top-down control of attention. However, the interrelationship between these neural markers is still underexplored. Further, the functional role of alpha band oscillations in auditory attention is underspecified as they could potentially implement target enhancement and distractor suppression. Together, this limits the understanding of the neuro-cognitive basis of attention.
The proposed project aims to address this problem by improving the investigators understanding of the cerebral mechanisms that underlie the control of auditory selective attention. The outlined research project will test the hypothesis that individuals with hearing impairment have deficits in auditory distractor inhibition that are reflected by ineffective neural suppression of irrelevant information. This hypothesis will be examined in three different lines of research. In research line 1, I will test a new framework in individuals who suffer from sensorineural hearing loss or tinnitus that allows to dissociate target selection and distractor suppression at the neural level based on electroencephalography (EEG) recordings. In research lines 2-3, I will then evaluate the potential of electric brain stimulation and neurofeedback to enhance auditory distractor suppression.The results of this project will have theoretical implications for current models of auditory attention and speech comprehension by specifying the functional role of oscillatory brain activity in normal hearing individual and hearing impaired populations. Beyond, this research will contribute new insights how the control of auditory selective attention could be implemented in a brain-computer interface.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 19
- Model description
- Experiment 1: * between-subject design * 3x4 = 3(hearing group) x 4(condition) * Masking: Single (Participant) * Masking Description: single-blind Experiment 2: * between-subject design * 3x4 = 3(hearing group) x 4(condition) * Masking: Single (Participant) * Masking Description: single-blind Experiment 3: * between-subject design * 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Experiment 4: * between-subject design * 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Experiment 5: * within-subject design * 2x2x4 = 2 (training) x 2(timepoint) x 4(condition) * Masking: Double (Participant, investigator) * Masking Description: double-blind Primary Purpose: Basic Science
| Arm | Type | Receives |
|---|---|---|
| Experiment 1 - Normal hearing - AAT | No intervention | –Each participant assigned to the normal hearing group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT). |
| Experiment 1 - Hearing impaired - AAT | No intervention | –Each participant assigned to the normal hearing impaired group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT). |
| Experiment 2 - normal hearing _ SAT | No intervention | –Each participant assigned to the normal hearing group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 2 - hearing impaired - SAT | No intervention | –Each participant assigned to the hearing impaired group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 2 - tinnitus - SAT | No intervention | –Each participant assigned to the tinnitus group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT). |
| Experiment 3 - normal hearing (tACS) - AAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 3 - normal hearing (sham) - AAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 3 - hearing impaired (tACS) - AAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 3 - hearing impaired (sham) - AAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 3 - tinnitus (tACS) - AAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 3 - tinnitus (sham) - AAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - normal hearing (tACS) - SAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - normal hearing (sham) - SAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - hearing impaired (tACS) - SAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - hearing impaired (sham) - SAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - tinnitus (tACS) - SAT | Experimental | Device: tACS - transcranial alternating current stimulationThe subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 4 - tinnitus (sham) - SAT | Sham comparator | Device: sham - transcranial alternating current stimulationThe subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex. Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded. |
| Experiment 5 - normal hearing (NF right) - AAT | Experimental | Device: NF - NeurofeedbackEach participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the right relative to the left parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded. |
| Experiment 5 - normal hearing (NF left) - AAT | Active comparator | Device: NF - NeurofeedbackEach participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the left relative to the right parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18-35 / 55-75
- German as first language
- Normal or corrected to normal vision
- Right-handed
- Normal hearing, hearing impairment or tinnitus (see specified inclusion)
Key exclusion criteria (13 listed)
- Non-symmetrical hearing loss
- Raised bi- or multilingually (second language acquired earlier than 6 years of age)
- Women who are currently pregnant or breastfeeding
- History of brain injury or any neurological disorder (y/n)
- Dyslexia
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 |
|---|---|---|
| tACS - transcranial alternating current stimulationTACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency. The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes. | Device | Experiment 3 - hearing impaired (tACS) - AAT, Experiment 3 - normal hearing (tACS) - AAT, Experiment 3 - tinnitus (tACS) - AAT, Experiment 4 - hearing impaired (tACS) - SAT, Experiment 4 - normal hearing (tACS) - SAT, Experiment 4 - tinnitus (tACS) - SAT |
| sham - transcranial alternating current stimulationDuring "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment. The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment. | Device | Experiment 3 - hearing impaired (sham) - AAT, Experiment 3 - normal hearing (sham) - AAT, Experiment 3 - tinnitus (sham) - AAT, Experiment 4 - hearing impaired (sham) - SAT, Experiment 4 - normal hearing (sham) - SAT, Experiment 4 - tinnitus (sham) - SAT |
| NF - NeurofeedbackNeurofeedback (NF) is a non-invasive approach that combines neurophysiological recordings with real-time sensory feedback (most studies use visual feedback). Through real-time NF, individuals thus can learn to regulate their brain activity. In this study, NF will be based on concurrent EEG recordings. During NF, participants will observe a space ship automatically navigating through a narrow tunnel. The modulation of their neural alpha power lateralization into the trained direction will be rewarded by the acceleration of the space ship, a modulation in the opposite direction will reduce speed and autopilot accuracy. | Device | Experiment 5 - normal hearing (NF left) - AAT, Experiment 5 - normal hearing (NF right) - AAT |
Primary outcome
Experiment 1 - EEG
Time frame: One study session of 4 hours and 40 minutes
The primary endpoint is the comparison of neural alpha power lateralization in response to target selection and distractor suppression in individuals with HL, TI and a NH control group.
Experiment 2 - EEG
Time frame: One study session of 4 hours and 40 minutes
The primary endpoint is the comparison of the neural tracking of the amplitude envelope of speech between individuals with HL, TI and NH.
Experiment 3 - AAT
Time frame: One study session of 4 hours and 40 minutes
The primary endpoint is the comparison of auditory attention performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Experiment 4 - SAT
Time frame: One study session of 4 hours and 40 minutes
The primary endpoint is the comparison of speech comprehension performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Experiment 5 - EEG 1
Time frame: two sessions of 4 hours and 40 minutes on separate days
The primary endpoint is the comparison of participants' ability to control alpha power lateralization index during training between training conditions (left NF training vs. right NF training).
9 secondary outcomes
Experiment 1 - AAT
Time frame: One study session of 4 hours and 40 minutes
Experiment 2 - SAT
Time frame: One study session of 4 hours and 40 minutes
Experiment 3 - EEG 1
Time frame: One study session of 4 hours and 40 minutes
Experiment 3 - EEG 2
Time frame: One study session of 4 hours and 40 minutes
Experiment 4 - EEG 1
Time frame: One study session of 4 hours and 40 minutes
Experiment 4 - EEG 2
Time frame: One study session of 4 hours and 40 minutes
Experiment 5 - EEG 2
Time frame: two sessions of 4 hours and 40 minutes on separate days
Experiment 5 - EEG 3
Time frame: two sessions of 4 hours and 40 minutes on separate days
Experiment 5 - AAT
Time frame: two sessions of 4 hours and 40 minutes on separate days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. The investigators intend to share the raw data of the included participants and the analysis code.
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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.
Basil Preisig, Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS - transcranial alternating current stimulation and NF - Neurofeedback in people with Hearing Loss and Attention Impaired, run by University of Zurich 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 13 inclusion and 13 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 7 Dec 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 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. Some participants in this study may receive a placebo. 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 Basil Preisig, Dr. (+41 44 634 21 85, basil.preisig@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiment 1 - EEG (time frame: One study session of 4 hours and 40 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2023.