Hearing ImpairmentNCT06663917
Clinical Evaluation of Frequency Allocation for Bimodal CI Users
A study testing Experimental frequency allocation table (FAT) - 438 Hz and Standard FAT - 188 Hz in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Experimental frequency allocation table (FAT) - 438 Hz and Standard FAT - 188 Hz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2024to 6 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
- Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
- Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
- Standard FAT use for all programs prior to study participation
- No known anatomical abnormalities in either ear
Show all 9Show fewer
- English speaking
- No known cognitive impairments
- At least 25% of subjects should use the Cochlear EA32 electrode
Who cannot join
- Under age 18
- Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
- Cognitively impaired
- Non-consistent device usage
- Greater than 70 dB hearing level pure tone average in the contralateral ear
- Normal hearing or mild hearing loss in the contralateral ear
- Non-standard FAT programs
- Use of any frequency transposition programming in hearing aid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.
- Conditions
- Hearing Impairment
- Being tested
- Experimental frequency allocation table (FAT) - 438 Hz, Standard FAT - 188 Hz
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental frequency allocation table (FAT) - 438 HzOther
The modified cochlear implant program ("experimental FAT") changes which frequencies are presented to the cochlear implant. The experimental FAT frequency of 438 Hz will be loaded onto the subjects processor via the CI Select Mobile App. Subjects will use the experimental FAT for one month.
Standard FAT - 188 HzOther
All subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month.
| Study group | Role | What they receive |
|---|---|---|
| Experienced Users | Experimental | All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation. Receives: Other: Experimental frequency allocation table (FAT) - 438 Hz; Other: Standard FAT - 188 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound Quality Questionnaire Score while using standard 188 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Measured: Baseline
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Measured: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Sound Quality Questionnaire Score while using standard 188 Hz FAT
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Measured: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Baseline
CNC word list score while using standard 188 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word list score while using standard 188 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word list score while using experimental 438 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Baseline
CNC word list score while using experimental 438 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word list score while using experimental 438 Hz FAT
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Measured: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Baseline
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Baseline
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Measured: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start6 Oct 2024
- Primary completion6 Oct 2027 (estimated)
- Study completion6 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Mario A. Svirsky, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663917
- Sponsor's protocol ID
- 24-00833
- Other IDs
- R01DC021980-01
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Data are available indefinitely in Databrary database (Link to be included when database is created). The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Frequency Allocation for Bimodal CI Users
- ClinicalTrials.gov ID
- NCT06663917
- Acronym / sponsor ID
- 24-00833
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 6 Oct 2027 (estimated)
- First posted
- 29 Oct 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.
This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced Users | Experimental | Other: Experimental frequency allocation table (FAT) - 438 Hz, Other: Standard FAT - 188 HzAll subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
- Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
- Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
- Standard FAT use for all programs prior to study participation
Key exclusion criteria (8 listed)
- Under age 18
- Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
- Cognitively impaired
- Non-consistent device usage
- Greater than 70 dB hearing level pure tone average in the contralateral ear
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 |
|---|---|---|
| Experimental frequency allocation table (FAT) - 438 HzThe modified cochlear implant program ("experimental FAT") changes which frequencies are presented to the cochlear implant. The experimental FAT frequency of 438 Hz will be loaded onto the subjects processor via the CI Select Mobile App. Subjects will use the experimental FAT for one month. | Other | Experienced Users |
| Standard FAT - 188 HzAll subjects will retain one program with the standard 188 Hz FAT. Subjects will use the standard FAT for one month. | Other | Experienced Users |
Primary outcome
Sound Quality Questionnaire Score while using standard 188 Hz FAT
Time frame: Baseline
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Sound Quality Questionnaire Score while using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using standard 188 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using experimental 438 Hz FAT
Time frame: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using experimental 438 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Baseline
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
Time frame: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Data are available indefinitely in Databrary database (Link to be included when database is created). The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Mario A. Svirsky, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental frequency allocation table (FAT) - 438 Hz and Standard FAT - 188 Hz in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
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 9 inclusion and 8 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 26 Jun 2026. 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 United States. 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 Mario Svirsky, PhD (212-263-7217, Mario.svirsky@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sound Quality Questionnaire Score while using standard 188 Hz FAT (time frame: Baseline). The study lists 15 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 26 Jun 2026.