Hearing Loss Clinical Trial
— NeurAttContrOfficial title:
Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
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).
Status | Recruiting |
Enrollment | 275 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. 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) Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | University of Luebeck |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One study session of 4 hours and 40 minutes | |
Primary | 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. | One study session of 4 hours and 40 minutes | |
Primary | 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. | One study session of 4 hours and 40 minutes | |
Primary | 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. | One study session of 4 hours and 40 minutes | |
Primary | 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). | two sessions of 4 hours and 40 minutes on separate days | |
Secondary | 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. | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 2 - SAT | The relation between neural speech tracking and speech comprehension performance in NH, HL, and TI | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 3 - EEG 1 | Comparison of neural alpha power lateralization between stimulation conditions (tACS vs. sham) | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 3 - EEG 2 | Comparison of event-related responses to target and distractor stimuli between stimulation conditions (tACS vs. sham) | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 4 - EEG 1 | Comparison of lateralization index between stimulation conditions (tACS vs. sham) | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 4 - EEG 2 | Comparison between neural tracking of target and distracting speech between stimulation conditions (tACS vs. sham) | One study session of 4 hours and 40 minutes | |
Secondary | Experiment 5 - EEG 2 | Comparison of auditory evoked responses to probes presented ipsilateral vs. contralateral to the trained hemisphere | two sessions of 4 hours and 40 minutes on separate days | |
Secondary | 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 | two sessions of 4 hours and 40 minutes on separate days | |
Secondary | Experiment 5 - AAT | Comparison of auditory attention performance across training conditions (left NF training vs. right NF training) | two sessions of 4 hours and 40 minutes on separate days |
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