Hearing LossARCogNCT05176561
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
A study testing Auditory-Cognitive Training and Non-auditory Cognitive Training in people with Hearing Loss and Deafness, run by Gallaudet University at 3 sites in United States.
Trial summary
The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users. The study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Deafness
- What is being tested?
- Auditory-Cognitive Training and Non-auditory Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2022to Apr 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age and over;
- Between 3 months and 3 years post cochlear implant activation;
- Passing score an cognitive screener (Callahan et al, 2002);
- Speech recognition scores on AZBio between 10% and 85%.
Who cannot join
- Single-sided deafness
- Non-fluent English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Vanderbilt University
Nashville, Tennessee, 37203-8820
Center for Hearing and Communication
New York, New York, 10004
Gallaudet University
Washington D.C., District of Columbia, 20002
About this study
Official title: Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users
The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users. The study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function.
Read the detailed description
Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users with Auditory-Brain Training is evaluating the performance of older cochlear implant users completing a customized auditory-cognitive brain training program. The goal is to determine the effectiveness of training based on speech recognition, neural responses, cognitive, and psychosocial function. Successful training could result in improved outcomes for communication and cognition, new client-centered care models, and better consumer access to effective training.
Specifically, investigators will assess two training programs to determine whether participants can improve speech understanding and speed, attention and memory, and communication in daily life. Thirty participants will be randomly assigned to one of two treatment groups: auditory-brain training or non-auditory brain training. Participants will complete two hours of training online at home or office. Participants will meet virtually with a clinician weekly to discuss progress.The study will help determine the best training methods for older adult cochlear implant users.
- Conditions
- Hearing Loss, Deafness
- Being tested
- Auditory-Cognitive Training, Non-auditory Cognitive Training
- Keywords
- Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-Cognitive TrainingBehavioural
Treatment Participants will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Participants with spend 1 hour auditory training use Angel Sound and one hour of auditory cognitive training using auditory portions of Posit Science. A clinical paradigm including reviewing results, providing strategies and positive feedback and strategies in the 1 hour virtual meeting of clinician and participant. Practice for next week is assigned.
Control group intervention follows the same time and procedure but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search).
Non-auditory Cognitive TrainingBehavioural
Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Control group intervention follows the same time and clinical paradigm, but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search).
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Auditory-Cognitive Training | Experimental | Behavioral: AR Group will complete sessions in their home or office via internet. Sessions will include independent work using computer software two hours per week and one hour meeting with the clinician each week. One half of the training is devoted to auditory training and one half to auditory cognitive activities. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant. Receives: Behavioral: Auditory-Cognitive Training |
| Control: Non-auditory Cognitive Training | Sham comparator | Behavioral: The CT Group will complete two hours of training in their home or office via internet. Sessions will include independent work using computer software two hours per week. Training exercises will be chosen from: Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Differences. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant. Receives: Behavioral: Non-auditory Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
Repeat sentences; % score of words repeated correctly; 0-100%; higher is better
Measured: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
Questionnaire rating for hearing ability pre and post treatment 10-95%; higher is better
Measured: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
Cochlear Implant Quality of Life (CIQOL) McRacken,T (2019) McRackan T, Hand B; Velozo CA, Dubno J. (2019) Cochlear Implant Quality of Life (CIQOL)(CIQOL-10 Global). J Speech Lang Hear Res. 62(9
Questionnaire measuring quality of life with hearing loss. Scores 1-5; higher is better
Measured: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
Raven Progressive Matrices Test. (2009).
Test of nonverbal reasoning. Scores number matrices completed from 0-60 matrices; higher is better.
Measured: Change from baseline Raven Progressive Matrices Test score at one-week post training. Change from baseline Raven Progressive Matrices Test score at 2 months post training.
Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).
Test of cognitive function adapted and normed for persons with hearing loss. Scores range from 40-160; higher is better.
Measured: Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-H) scores at one-week post training. Change from RBANS-H baseline at 2 months.
Revised Hearing Handicap Inventory and Screening Tool based on Psychometric Reevaluation of the Hearing Handicap Inventories for the Elderly and Adults (RHHI). Cassarly C, Matthews L, Simpson A et al.( 2020)
Questionnaire to assess perceived hearing handicap associated with a hearing loss or effects of hearing loss on an individual's quality of life. Scores range from 0 to100 with 0-52 for emotional sub-scale and 0-48 for social-situational; lower scores are better.
Measured: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
Test of cognitive abilities. Scores time to completion; lower is better.
Measured: Change from baseline Trail Making Test scores at 1-week post training, at 2 months post training. at 2 months post training.
Neural Response to sound Electrophysological response to sound.
Electrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are better.
Measured: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 May 2022
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gallaudet University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Diane Brewer, Gallaudet University
- Investigators
- Diane M Brewer, MA, Principal investigator, Gallaudet UniversityClaire M Bernstein, PhD, Principal investigator, Gallaudet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176561
- Sponsor's protocol ID
- GallaudetU
- Acronym
- ARCog
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu QJ, Galvin JJ 3rd. Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. Semin Hear. 2007 May 1;28(2):10.1055/s-2007-973440. doi: 10.1055/s-2007-973440.
PubMed 24273377Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
PubMed 16888038Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
PubMed 21829134Claes AJ, Mertens G, Gilles A, Hofkens-Van den Brandt A, Fransen E, Van Rompaey V, Van de Heyning P. The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study. Front Neurosci. 2016 Nov 15;10:512. doi: 10.3389/fnins.2016.00512. eCollection 2016.
PubMed 27895549Sanchez-Cubillo I, Perianez JA, Adrover-Roig D, Rodriguez-Sanchez JM, Rios-Lago M, Tirapu J, Barcelo F. Construct validity of the Trail Making Test: role of task-switching, working memory, inhibition/interference control, and visuomotor abilities. J Int Neuropsychol Soc. 2009 May;15(3):438-50. doi: 10.1017/S1355617709090626.
PubMed 19402930Raven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.
McRackan TR, Hand BN; Cochlear Implant Quality of Life Development Consortium; Velozo CA, Dubno JR. Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global). J Speech Lang Hear Res. 2019 Sep 20;62(9):3554-3563. doi: 10.1044/2019_JSLHR-H-19-0142. Epub 2019 Sep 4.
PubMed 31479616Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.
PubMed 9046067
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT05176561
- Acronym / sponsor ID
- ARCog / GallaudetU
- Conditions
- Hearing Loss, Deafness
- Keywords
- Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gallaudet UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 1 May 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Jan 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.
The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users. The study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function.
Detailed description
Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users with Auditory-Brain Training is evaluating the performance of older cochlear implant users completing a customized auditory-cognitive brain training program. The goal is to determine the effectiveness of training based on speech recognition, neural responses, cognitive, and psychosocial function. Successful training could result in improved outcomes for communication and cognition, new client-centered care models, and better consumer access to effective training.
Specifically, investigators will assess two training programs to determine whether participants can improve speech understanding and speed, attention and memory, and communication in daily life. Thirty participants will be randomly assigned to one of two treatment groups: auditory-brain training or non-auditory brain training. Participants will complete two hours of training online at home or office. Participants will meet virtually with a clinician weekly to discuss progress.The study will help determine the best training methods for older adult cochlear implant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
| Arm | Type | Receives |
|---|---|---|
| Treatment: Auditory-Cognitive Training | Experimental | Behavioral: Auditory-Cognitive TrainingBehavioral: AR Group will complete sessions in their home or office via internet. Sessions will include independent work using computer software two hours per week and one hour meeting with the clinician each week. One half of the training is devoted to auditory training and one half to auditory cognitive activities. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant. |
| Control: Non-auditory Cognitive Training | Sham comparator | Behavioral: Non-auditory Cognitive TrainingBehavioral: The CT Group will complete two hours of training in their home or office via internet. Sessions will include independent work using computer software two hours per week. Training exercises will be chosen from: Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Differences. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age and over;
- Between 3 months and 3 years post cochlear implant activation;
- Passing score an cognitive screener (Callahan et al, 2002);
- Speech recognition scores on AZBio between 10% and 85%.
Key exclusion criteria (2 listed)
- Single-sided deafness
- Non-fluent English
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-Cognitive TrainingTreatment Participants will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Participants with spend 1 hour auditory training use Angel Sound and one hour of auditory cognitive training using auditory portions of Posit Science. A clinical paradigm including reviewing results, providing strategies and positive feedback and strategies in the 1 hour virtual meeting of clinician and participant. Practice for next week is assigned. Control group intervention follows the same time and procedure but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search). | Behavioural | Treatment: Auditory-Cognitive Training |
| Non-auditory Cognitive TrainingParticipant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Control group intervention follows the same time and clinical paradigm, but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search). | Behavioural | Control: Non-auditory Cognitive Training |
Primary outcome
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
Time frame: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
Repeat sentences; % score of words repeated correctly; 0-100%; higher is better
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
Time frame: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
Questionnaire rating for hearing ability pre and post treatment 10-95%; higher is better
Cochlear Implant Quality of Life (CIQOL) McRacken,T (2019) McRackan T, Hand B; Velozo CA, Dubno J. (2019) Cochlear Implant Quality of Life (CIQOL)(CIQOL-10 Global). J Speech Lang Hear Res. 62(9
Time frame: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
Questionnaire measuring quality of life with hearing loss. Scores 1-5; higher is better
Raven Progressive Matrices Test. (2009).
Time frame: Change from baseline Raven Progressive Matrices Test score at one-week post training. Change from baseline Raven Progressive Matrices Test score at 2 months post training.
Test of nonverbal reasoning. Scores number matrices completed from 0-60 matrices; higher is better.
Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).
Time frame: Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-H) scores at one-week post training. Change from RBANS-H baseline at 2 months.
Test of cognitive function adapted and normed for persons with hearing loss. Scores range from 40-160; higher is better.
Revised Hearing Handicap Inventory and Screening Tool based on Psychometric Reevaluation of the Hearing Handicap Inventories for the Elderly and Adults (RHHI). Cassarly C, Matthews L, Simpson A et al.( 2020)
Time frame: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
Questionnaire to assess perceived hearing handicap associated with a hearing loss or effects of hearing loss on an individual's quality of life. Scores range from 0 to100 with 0-52 for emotional sub-scale and 0-48 for social-situational; lower scores are better.
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
Time frame: Change from baseline Trail Making Test scores at 1-week post training, at 2 months post training. at 2 months post training.
Test of cognitive abilities. Scores time to completion; lower is better.
Neural Response to sound Electrophysological response to sound.
Time frame: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training
Electrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are better.
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 30 Mar 2026.
- Background: PubMed 24273377Fu QJ, Galvin JJ 3rd. Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. Semin Hear. 2007 May 1;28(2):10.1055/s-2007-973440. doi: 10.1055/s-2007-973440.
- Background: PubMed 16888038Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
- Background: PubMed 21829134Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
- Background: PubMed 27895549Claes AJ, Mertens G, Gilles A, Hofkens-Van den Brandt A, Fransen E, Van Rompaey V, Van de Heyning P. The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study. Front Neurosci. 2016 Nov 15;10:512. doi: 10.3389/fnins.2016.00512. eCollection 2016.
- Background: PubMed 19402930Sanchez-Cubillo I, Perianez JA, Adrover-Roig D, Rodriguez-Sanchez JM, Rios-Lago M, Tirapu J, Barcelo F. Construct validity of the Trail Making Test: role of task-switching, working memory, inhibition/interference control, and visuomotor abilities. J Int Neuropsychol Soc. 2009 May;15(3):438-50. doi: 10.1017/S1355617709090626.
- BackgroundRaven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.
- Background: PubMed 31479616McRackan TR, Hand BN; Cochlear Implant Quality of Life Development Consortium; Velozo CA, Dubno JR. Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global). J Speech Lang Hear Res. 2019 Sep 20;62(9):3554-3563. doi: 10.1044/2019_JSLHR-H-19-0142. Epub 2019 Sep 4.
- Background: PubMed 9046067Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.
- 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.
Diane M Brewer, MA principal investigator
Gallaudet University
Claire M Bernstein, PhD principal investigator
Gallaudet University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-Cognitive Training and Non-auditory Cognitive Training in people with Hearing Loss and Deafness, run by Gallaudet University at 3 sites 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
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?
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012) (time frame: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.). The study lists 8 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 NCT05176561, which also lists 8 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 30 Mar 2026.