Asymmetric Sensorineural Hearing LossNCT05441891
Effect of Modulated Auditory Stimulation on Interaural Auditory Perception
A study testing Auditory intervention filter-modulated group in people with Asymmetric Sensorineural Hearing Loss, run by University of Alcala at 1 site in Spain.
Trial summary
This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression. Read more about this study
- Who is it for?
- Ages 31 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymmetric Sensorineural Hearing Loss
- What is being tested?
- Auditory intervention filter-modulated group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2022to 21 Oct 2022
- 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 31 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recruited from Health Centre Mejorada del Campo (Madrid, Spain)
Who cannot join
- Having significant hearing loss
- Having acute otological process
- Having psychotic disease
- Having epilepsy
- Having serious illness
- Having pregnancy
- Used to try alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States
This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.
Read the detailed description
The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process.
Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).
The study variables collected at 3 months were pure-tone audiometry (air conduction).
- Conditions
- Asymmetric Sensorineural Hearing Loss
- Being tested
- Auditory intervention filter-modulated group
- Keywords
- hearing asymmetry, mental disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory intervention filter-modulated groupOther
Also called Bérard´s method
Intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks).
The musical intervention was always performed with the same songs and in the same order using original CDs, heard through headphones (Beyerdynamic, DT 250 / 80 ohm. GMBH \& Co. KG, Theresienstr. 8 D-74072 Heilbronn, Germany). The music was played with a sound system (Panasonic MASH, No. SA-PM24. Hamburg, Germany). and filtered through an equalizer called Earducator (Hollagen Designs, PÍO. Box 43 7864 Bergvliet W.Cape - South Africa) that modulates music by alternating low and high tones with an unpredictable cadence, preventing habituation. It also allows very narrow band complementary filters to attenuate (by about 40 dB) abnormally perceived frequencies (hyper-hearing peaks): filters in: 1 kHz - 1,5 kHz - 2kHz - 3 kHz - 4 kHz - 8kHz.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants assigned to the control group are cited to the Health centre, but they do not suffer any intervention. These subjects followed the same evaluation and data collection process. |
| Auditory intervention filter-modulated | Active comparator | Participants assigned to this group listened classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Receives: Other: Auditory intervention filter-modulated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months
Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry
Measured: Change from Baseline hearing threshold at 3 months
Anxiety and depression level on the Goldberg scale
To discriminate between these two entities. The following cut-off points were used: a total Anxiety score > 4 detects 73% of all cases of anxiety; a total Depression score >3 detects 82% of all cases of depression
Measured: One month
Anxiety level on the Hamilton scale
It is a clinician-administered scale on which each item is rated from 0 to 4. It yields a score in the range of 0 to 56. The following cut-off points were used: 0-5 points (No anxiety), >5 points (Anxiety).
Measured: One month
Depression level on the Hamilton scale
Each item is rated on a three- or five-point scale, with a score from 0 to 2 or 0 to 4, respectively. It yields a total score in the range of 0 to 52. The following cut-off points were used to assess depression: No depression: 0-7; Depression: >7
Measured: One month
Secondary outcomes (11)
Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Measured: Three months between the first and second measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start17 Jun 2022
- Primary completion19 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asymmetric Sensorineural Hearing LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, pre-post study design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Germain, University of Alcala
- Investigators
- Beatriz Estalayo-Gutierrez, MD, PhD, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441891
- Sponsor's protocol ID
- CREC/UH/2022/05
- Status last verified
- Nov 2022
- First submitted
- 22 Jun 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frassle S, Paulus FM, Krach S, Schweinberger SR, Stephan KE, Jansen A. Mechanisms of hemispheric lateralization: Asymmetric interhemispheric recruitment in the face perception network. Neuroimage. 2016 Jan 1;124(Pt A):977-988. doi: 10.1016/j.neuroimage.2015.09.055. Epub 2015 Oct 9.
PubMed 26439515Brancucci A, Babiloni C, Rossini PM, Romani GL. Right hemisphere specialization for intensity discrimination of musical and speech sounds. Neuropsychologia. 2005;43(13):1916-23. doi: 10.1016/j.neuropsychologia.2005.03.005. Epub 2005 Mar 21.
PubMed 16168732
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States
- ClinicalTrials.gov ID
- NCT05441891
- Acronym / sponsor ID
- CREC/UH/2022/05
- Conditions
- Asymmetric Sensorineural Hearing Loss
- Keywords
- hearing asymmetry, mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 1 Jul 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 analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.
Detailed description
The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process.
Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).
The study variables collected at 3 months were pure-tone audiometry (air conduction).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel, pre-post study design
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants assigned to the control group are cited to the Health centre, but they do not suffer any intervention. These subjects followed the same evaluation and data collection process. |
| Auditory intervention filter-modulated | Active comparator | Other: Auditory intervention filter-modulated groupParticipants assigned to this group listened classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). |
Who may qualify
- Ages
- 31 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recruited from Health Centre Mejorada del Campo (Madrid, Spain)
Key exclusion criteria (7 listed)
- Having significant hearing loss
- Having acute otological process
- Having psychotic disease
- Having epilepsy
- Having serious illness
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 |
|---|---|---|
| Auditory intervention filter-modulated groupAlso: Bérard´s methodIntervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). The musical intervention was always performed with the same songs and in the same order using original CDs, heard through headphones (Beyerdynamic, DT 250 / 80 ohm. GMBH \& Co. KG, Theresienstr. 8 D-74072 Heilbronn, Germany). The music was played with a sound system (Panasonic MASH, No. SA-PM24. Hamburg, Germany). and filtered through an equalizer called Earducator (Hollagen Designs, PÍO. Box 43 7864 Bergvliet W.Cape - South Africa) that modulates music by alternating low and high tones with an unpredictable cadence, preventing habituation. It also allows very narrow band complementary filters to attenuate (by about 40 dB) abnormally perceived frequencies (hyper-hearing peaks): filters in: 1 kHz - 1,5 kHz - 2kHz - 3 kHz - 4 kHz - 8kHz. | Other | Auditory intervention filter-modulated |
Primary outcome
Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months
Time frame: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry
Anxiety and depression level on the Goldberg scale
Time frame: One month
To discriminate between these two entities. The following cut-off points were used: a total Anxiety score > 4 detects 73% of all cases of anxiety; a total Depression score >3 detects 82% of all cases of depression
Anxiety level on the Hamilton scale
Time frame: One month
It is a clinician-administered scale on which each item is rated from 0 to 4. It yields a score in the range of 0 to 56. The following cut-off points were used: 0-5 points (No anxiety), >5 points (Anxiety).
Depression level on the Hamilton scale
Time frame: One month
Each item is rated on a three- or five-point scale, with a score from 0 to 2 or 0 to 4, respectively. It yields a total score in the range of 0 to 52. The following cut-off points were used to assess depression: No depression: 0-7; Depression: >7
11 secondary outcomes
Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz
Time frame: Three months between the first and second measure
Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz
Time frame: Three months between the first and second measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 26439515Frassle S, Paulus FM, Krach S, Schweinberger SR, Stephan KE, Jansen A. Mechanisms of hemispheric lateralization: Asymmetric interhemispheric recruitment in the face perception network. Neuroimage. 2016 Jan 1;124(Pt A):977-988. doi: 10.1016/j.neuroimage.2015.09.055. Epub 2015 Oct 9.
- Background: PubMed 16168732Brancucci A, Babiloni C, Rossini PM, Romani GL. Right hemisphere specialization for intensity discrimination of musical and speech sounds. Neuropsychologia. 2005;43(13):1916-23. doi: 10.1016/j.neuropsychologia.2005.03.005. Epub 2005 Mar 21.
- Individual participant dataSharing planned: No
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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.
Beatriz Estalayo-Gutierrez, MD, PhD principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory intervention filter-modulated group in people with Asymmetric Sensorineural Hearing Loss, run by University of Alcala at 1 site in Spain.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months (time frame: Change from Baseline hearing threshold at 3 months). The study lists 14 primary outcomes in all. 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 NCT05441891, which also lists 2 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 2 Nov 2022.