Cochlear ImplantNCT03886168
Pediatric Image-Guided Cochlear Implant Programming
A study testing Signal processing intervention of a biomedical device in people with Cochlear Implant, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss… Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- Signal processing intervention of a biomedical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2019to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 13 years of age
- Prelingual onset of deafness
- At least one CI and bilateral moderate to profound sensorineural hearing loss
- for children with a single CI, audiometric thresholds in the non-CI ear must be consistent with at least a moderate to profound sensorineural hearing loss
- Cochlear implantation prior to 4 years of age
- Nonverbal cognitive abilities within the typical range
Show all 9Show fewer
- No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment
- Pre-operative CT scan of head performed as standard of care CI work-up
- Post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed consent
Who cannot join
- Severe anatomical abnormality(s) of the temporal bone.
- Onset of moderate-to-profound sensorineural hearing loss after 2 years of age
- Nonverbal intelligence standard score > 85
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss; however, many pediatric CI recipients display persistent speech and language disorders despite early implantation and associated speech/language intervention. Cochlear implants are programmed via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care (SOC) mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients. Measures of hearing were gathered at baseline, 12 month and 24 month time points.
Read the detailed description
Although children with cochlear implants (CIs) have significantly improved speech, language, and reading outcomes relative to previous generation CI recipients, too many pediatric CI users still display persistent speech, language, and reading difficulties despite early implantation and early intervention. Children with CIs typically lag behind their peers with normal hearing (NH) by 1 or more years on measures of speech, language and/or reading. Though these persistent delays can be attributed in part to a period of auditory deprivation prior to implantation, increasing evidence suggests that a degraded CI signal is also implicated in poorer development of auditory, speech, language, and reading skills for pediatric CI recipients. A related developmental path to reading also disrupted from the degraded CI signal is phonological awareness (PA) because PA is predicated, in part, on speech recognition.
A procedure developed by Noble and colleagues, image-guided CI programming (IGCIP), significantly improves auditory function, speech recognition, and distally, receptive language abilities for adult CI users. The investigators have preliminary evidence that pediatric CI recipients also significantly benefit from IGCIP. But there is a need to systematically investigate IGCIP in children to determine whether this individualized intervention yields a) associated benefits in auditory function and b) related improvements in speech, language, PA and/or reading. Thus, our primary goal is to evaluate the effects of IGCIP on auditory function, speech recognition, PA and reading, as well as speech and language abilities in pediatric CI recipients within the context of a double blind, waitlist controlled randomized clinical trial (RCT). The investigators obtained psychophysical estimates of auditory function and speech recognition, PA, reading, speech, and language abilities for 47 pediatric CI users in a baseline assessment and assessments 12 and 24 months to test the impact of IGCIP. The investigators examined the immediate (short-term) and longer-term effects over a 2-year period by comparing outcomes between groups for those randomly assigned to immediate (n = 24) or deferred (n = 23) IGCIP using a waitlist control study design (deferred IGCIP). The initial comparison was for immediate and deferred IGCIP groups at 12 months. The deferred group then received the IGCIP intervention and both groups were followed for an additional 12 months (total enrollment for 24 months). The proposed research includes the following aims and specific hypotheses:
Aim 1: Auditory function. The investigators compared auditory function and speech recognition of the immediate and waitlist control participants. Original hypotheses were as follows: Hypothesis 1a: There will be significant positive short-term gains (12 months) in spectral and/or temporal resolution as well as speech recognition-particularly in noise-for children immediately receiving IGCIP as compared to waitlist controls. This hypothesis will be tested by comparing the difference in the amount of change in scores within-subjects (pre- to post-IGCIP gain) between the groups (treated vs. untreated) controlling for initial scores. Hypothesis 1b: IGCIP gain in spectral and/or temporal resolution will significantly predict gain in speech recognition. This hypothesis was tested via regression analyses of change in speech recognition scores on change in resolution, controlling for baseline values and also controlling for baseline levels of speech recognition.
Aim 2: PA and reading. The investigators will explore the complex relationships amongst auditory function, speech recognition, PA, and reading ability. Hypothesis 2a: Differential growth in spectral/temporal resolution and/or speech recognition will predict growth in PA, which in turn will predict mediated growth in reading. Hypothesis 2b: Growth in PA will be associated with amount of IGCIP benefit (gain) and will mediate growth in reading, which will be tested via cross-legged panel and path analyses. Note that testing these hypotheses is not dependent on the outcomes of Aim 1 as only variable gain in the Aim 1 measures (e.g., speech recognition) are required for aim 2 analyses, not a significant between-group difference for IGCIP in Aim 1.
Aim 3: Speech and language. The investigators will compare pre- and post-IGCIP receptive and expressive language abilities and speech production of pediatric CI recipients to the waitlist control group. The investigators will test these skills at various time points on standardized and clinical measures of 1) receptive language, 2) expressive language, and 3) speech production (articulation and acoustic analyses). Hypothesis 3a: There will be significant differences between groups for positive growth in speech and language and this growth will be predicted by the relative improvement in auditory function (aim 1) from IGCIP while controlling for baseline levels of working memory. Hypothesis 3b: Spectral/temporal resolution and speech recognition and/or PA will serve as mediators of expressive and receptive language gains and speech production gains both within and between groups. 3a and 3b will also be tested using mixed effects modeling and regression analyses to examine these "downstream" effects. Even if no between group differences in Aim 1 and/or Aim 2 are seen, the investigators will nonetheless be able to test whether spectral/temporal resolution, speech recognition, and/or PA predict growth in receptive and/or expressive language and/or changes in speech production (including subclinical acoustic analyses).
- Conditions
- Cochlear Implant
- Being tested
- Signal processing intervention of a biomedical device
- Keywords
- Pediatric Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal processing intervention of a biomedical deviceOther
This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
| Study group | Role | What they receive |
|---|---|---|
| Immediate IGCIP | Experimental | Immediate signal processing intervention of a biomedical device Receives: Other: Signal processing intervention of a biomedical device |
| Deferred IGCIP | Active comparator | Delayed signal processing intervention of a biomedical device Receives: Other: Signal processing intervention of a biomedical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral Resolution (Spectral Modulation Detection or SMD)
The spectral modulation detection (SMD) task of spectral resolution will use a 3-interval, 2-alternative forced-choice procedure. The participant will discriminate between flat-spectrum and spectrally-modulated noise presented at 65 dB SPL. The investigators will use a broadband stimulus and assess spectral modulation rates of 0.5 and 1.0 cycle per octave. Threshold will be expressed in modulation depth (in dB) for each modulation rate tested.
Measured: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).
Secondary outcomes (1)
Temporal Resolution (Sinusoidal Amplitude Modulation (SAM) Detection
The temporal resolution task includes sinusoidal amplitude modulation (SAM) detection with a 3-interval, 2-alternative forced-choice procedure.The participant will discriminate between noises with a flat temporal envelope and sinusoidal amplitude modulation. The investigators will use a broadband stimulus at 65 dB SPL and assess amplitude modulation rates of 4, 32, and 128 Hz. SAM threshold will be expressed in 20 log m (in dB), with m representing the modulation index (0 to 1).
Measured: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start30 Jun 2019
- Primary completion31 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- The total sample (n = 47) was randomly assigned to either immediate IGCIP intervention (n = 24) or a deferred waitlist condition (n = 23). Both groups were monitored for 24 months, with testing at time 1 (baseline), time 2 (12 months) and time 3 (24 months). After 12 months, the deferred treatment group received the IGCIP intervention. At the conclusion of the project, the investigators had 12 months of data on untreated growth, followed by 12 months data of treated growth in the deferred treatment group, and 24 months of total growth in the immediate IGCIP treatment group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Stephen Camarata, Vanderbilt University Medical Center
- Investigators
- Rene Gifford, PhD, Principal investigator, Vanderbilt University Medical CenterStephen Camarata, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886168
- Sponsor's protocol ID
- 190095
- Other IDs
- 1R01DC017683-01A1
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2019
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeFreese A, Camarata S, Sunderhaus L, Holder J, Berg K, Lighterink M, Gifford R. The impact of spectral and temporal processing on speech recognition in children with cochlear implants. Sci Rep. 2024 Jun 18;14(1):14094. doi: 10.1038/s41598-024-63932-w.
PubMed 38890428Camarata S, Lighterink M, Sunderhaus L, Labadie R, Gifford R. Phonological processing, oral language abilities, and reading comprehension in children with cochlear implants. Sci Rep. 2026 Jan 10;15(1):45800. doi: 10.1038/s41598-025-22358-8.
PubMed 41519852
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy
- ClinicalTrials.gov ID
- NCT03886168
- Acronym / sponsor ID
- 190095
- Conditions
- Cochlear Implant
- Keywords
- Pediatric Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 24 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss; however, many pediatric CI recipients display persistent speech and language disorders despite early implantation and associated speech/language intervention. Cochlear implants are programmed via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care (SOC) mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients. Measures of hearing were gathered at baseline, 12 month and 24 month time points.
Detailed description
Although children with cochlear implants (CIs) have significantly improved speech, language, and reading outcomes relative to previous generation CI recipients, too many pediatric CI users still display persistent speech, language, and reading difficulties despite early implantation and early intervention. Children with CIs typically lag behind their peers with normal hearing (NH) by 1 or more years on measures of speech, language and/or reading. Though these persistent delays can be attributed in part to a period of auditory deprivation prior to implantation, increasing evidence suggests that a degraded CI signal is also implicated in poorer development of auditory, speech, language, and reading skills for pediatric CI recipients. A related developmental path to reading also disrupted from the degraded CI signal is phonological awareness (PA) because PA is predicated, in part, on speech recognition.
A procedure developed by Noble and colleagues, image-guided CI programming (IGCIP), significantly improves auditory function, speech recognition, and distally, receptive language abilities for adult CI users. The investigators have preliminary evidence that pediatric CI recipients also significantly benefit from IGCIP. But there is a need to systematically investigate IGCIP in children to determine whether this individualized intervention yields a) associated benefits in auditory function and b) related improvements in speech, language, PA and/or reading. Thus, our primary goal is to evaluate the effects of IGCIP on auditory function, speech recognition, PA and reading, as well as speech and language abilities in pediatric CI recipients within the context of a double blind, waitlist controlled randomized clinical trial (RCT). The investigators obtained psychophysical estimates of auditory function and speech recognition, PA, reading, speech, and language abilities for 47 pediatric CI users in a baseline assessment and assessments 12 and 24 months to test the impact of IGCIP. The investigators examined the immediate (short-term) and longer-term effects over a 2-year period by comparing outcomes between groups for those randomly assigned to immediate (n = 24) or deferred (n = 23) IGCIP using a waitlist control study design (deferred IGCIP). The initial comparison was for immediate and deferred IGCIP groups at 12 months. The deferred group then received the IGCIP intervention and both groups were followed for an additional 12 months (total enrollment for 24 months). The proposed research includes the following aims and specific hypotheses:
Aim 1: Auditory function. The investigators compared auditory function and speech recognition of the immediate and waitlist control participants. Original hypotheses were as follows: Hypothesis 1a: There will be significant positive short-term gains (12 months) in spectral and/or temporal resolution as well as speech recognition-particularly in noise-for children immediately receiving IGCIP as compared to waitlist controls. This hypothesis will be tested by comparing the difference in the amount of change in scores within-subjects (pre- to post-IGCIP gain) between the groups (treated vs. untreated) controlling for initial scores. Hypothesis 1b: IGCIP gain in spectral and/or temporal resolution will significantly predict gain in speech recognition. This hypothesis was tested via regression analyses of change in speech recognition scores on change in resolution, controlling for baseline values and also controlling for baseline levels of speech recognition.
Aim 2: PA and reading. The investigators will explore the complex relationships amongst auditory function, speech recognition, PA, and reading ability. Hypothesis 2a: Differential growth in spectral/temporal resolution and/or speech recognition will predict growth in PA, which in turn will predict mediated growth in reading. Hypothesis 2b: Growth in PA will be associated with amount of IGCIP benefit (gain) and will mediate growth in reading, which will be tested via cross-legged panel and path analyses. Note that testing these hypotheses is not dependent on the outcomes of Aim 1 as only variable gain in the Aim 1 measures (e.g., speech recognition) are required for aim 2 analyses, not a significant between-group difference for IGCIP in Aim 1.
Aim 3: Speech and language. The investigators will compare pre- and post-IGCIP receptive and expressive language abilities and speech production of pediatric CI recipients to the waitlist control group. The investigators will test these skills at various time points on standardized and clinical measures of 1) receptive language, 2) expressive language, and 3) speech production (articulation and acoustic analyses). Hypothesis 3a: There will be significant differences between groups for positive growth in speech and language and this growth will be predicted by the relative improvement in auditory function (aim 1) from IGCIP while controlling for baseline levels of working memory. Hypothesis 3b: Spectral/temporal resolution and speech recognition and/or PA will serve as mediators of expressive and receptive language gains and speech production gains both within and between groups. 3a and 3b will also be tested using mixed effects modeling and regression analyses to examine these "downstream" effects. Even if no between group differences in Aim 1 and/or Aim 2 are seen, the investigators will nonetheless be able to test whether spectral/temporal resolution, speech recognition, and/or PA predict growth in receptive and/or expressive language and/or changes in speech production (including subclinical acoustic analyses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The total sample (n = 47) was randomly assigned to either immediate IGCIP intervention (n = 24) or a deferred waitlist condition (n = 23). Both groups were monitored for 24 months, with testing at time 1 (baseline), time 2 (12 months) and time 3 (24 months). After 12 months, the deferred treatment group received the IGCIP intervention. At the conclusion of the project, the investigators had 12 months of data on untreated growth, followed by 12 months data of treated growth in the deferred treatment group, and 24 months of total growth in the immediate IGCIP treatment group.
| Arm | Type | Receives |
|---|---|---|
| Immediate IGCIP | Experimental | Other: Signal processing intervention of a biomedical deviceImmediate signal processing intervention of a biomedical device |
| Deferred IGCIP | Active comparator | Other: Signal processing intervention of a biomedical deviceDelayed signal processing intervention of a biomedical device |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 4 to 13 years of age
- Prelingual onset of deafness
- At least one CI and bilateral moderate to profound sensorineural hearing loss
- Cochlear implantation prior to 4 years of age
- Nonverbal cognitive abilities within the typical range
Key exclusion criteria (3 listed)
- Severe anatomical abnormality(s) of the temporal bone.
- Onset of moderate-to-profound sensorineural hearing loss after 2 years of age
- Nonverbal intelligence standard score > 85
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 |
|---|---|---|
| Signal processing intervention of a biomedical deviceThis is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software. | Other | Deferred IGCIP, Immediate IGCIP |
Primary outcome
Spectral Resolution (Spectral Modulation Detection or SMD)
Time frame: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).
The spectral modulation detection (SMD) task of spectral resolution will use a 3-interval, 2-alternative forced-choice procedure. The participant will discriminate between flat-spectrum and spectrally-modulated noise presented at 65 dB SPL. The investigators will use a broadband stimulus and assess spectral modulation rates of 0.5 and 1.0 cycle per octave. Threshold will be expressed in modulation depth (in dB) for each modulation rate tested.
1 secondary outcome
Temporal Resolution (Sinusoidal Amplitude Modulation (SAM) Detection
Time frame: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38890428DeFreese A, Camarata S, Sunderhaus L, Holder J, Berg K, Lighterink M, Gifford R. The impact of spectral and temporal processing on speech recognition in children with cochlear implants. Sci Rep. 2024 Jun 18;14(1):14094. doi: 10.1038/s41598-024-63932-w.
- Results publication: PubMed 41519852Camarata S, Lighterink M, Sunderhaus L, Labadie R, Gifford R. Phonological processing, oral language abilities, and reading comprehension in children with cochlear implants. Sci Rep. 2026 Jan 10;15(1):45800. doi: 10.1038/s41598-025-22358-8.
- 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.
Rene Gifford, PhD principal investigator
Vanderbilt University Medical Center
Stephen Camarata, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signal processing intervention of a biomedical device in people with Cochlear Implant, run by Vanderbilt University Medical Center 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 3 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 24 Aug 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?
Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Spectral Resolution (Spectral Modulation Detection or SMD) (time frame: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).). 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 NCT03886168, 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 24 Aug 2026.