Hearing Loss, SensorineuralBEARSNCT05808543
BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
A study testing Both EARS training package (BEARS) in people with Hearing Loss, Sensorineural and Hearing Loss, run by Guy's and St Thomas' NHS Foundation Trust at 13 sites in United Kingdom.
Trial summary
The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Deafness
- What is being tested?
- Both EARS training package (BEARS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 27 Jul 2023to 31 Oct 2026
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
- Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.
- Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) *(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)
- Participant has stable programmes (defined as no longer using progressive programmes to work through).
- Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.
- Participant is aged 8-16 years, inclusive.
Who cannot join
- Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
- Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
- Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
- Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
- Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
- Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming.
Show all 13Show fewer
- Participant is refusing to consent to trial activities/protocol.
- Participant is awaiting reimplantation following device failure or infection.
- Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month).
- Participant is a fulltime boarder at a boarding school
- Participant has unresolvable issues found in device checks that render one of the implants unusable.
- Participant is a female that is pregnant.
- Participant has a diagnosis of epilepsy or history of seizures of any kind.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Liz Arram, MSc contact
13 sites in 1 country
United Kingdom13 sites, 12 recruiting
- Active, not recruiting
The Midlands Hearing Implant Programme (Children's Service)
Birmingham, Birmingham, B4 7ET
- Recruiting
Yorkshire Auditory Implant Service
Bradford, Bradford, BD9 6RJ
- Recruiting
Emmeline Centre for Hearing Implants
Cambridge, Cambridge, CB2 0QQ
- Recruiting
Scottish Cochlear Implant Programme
Kilmarnock, Kilmarnock, KA2 0BE
- Recruiting
St Thomas' Hospital Hearing Implant Centre
London, London, SE1 7EH
- Recruiting
St George's Auditory Implant Service
London, London, SW17 OQT
- Recruiting
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
London, London, WC1E 6DG
- Recruiting
Great Ormond Street Cochlear Implant Programme
London, London, WC1N 3JH
- Recruiting
The Richard Ramsden Centre for Hearing Implants
Manchester, Manchester, M13 9WL
- Recruiting
North East Regional Cochlear Implant Programme
Middlesbrough, Middlesborough, TS4 3BW
- Recruiting
Nottingham Auditory Implant Programme
Nottingham, Nottingham, NG1 5DU
- Recruiting
Oxford Auditory Implant Centre
Oxford, Oxford, OX3 9DU
- Recruiting
University of Southampton Auditory Implant Service
Southampton, Southampton, SO17 1BJ
About this study
Official title: A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants
The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants.
The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.
Read the detailed description
Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently over 6000 people have bilateral cochlear implants in the United Kingdom, most of these are children.
Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. Our 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles.
To address these issues, we have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening.
The aim of this trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants. The study will be carried out in clinical cochlear implant departments in National Health Service or University hospitals.
Participants will be randomly allocated into one of two groups:
- Receiving the BEARS training package to use for 3-months alongside usual care
- Continue with usual care
The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.
Participants and clinicians can also consent to qualitative or process evaluation interviews, which are BEARS sub-studies
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Deafness, Hearing Impaired Children and Adolescents
- Being tested
- Both EARS training package (BEARS), Usual Care
- Keywords
- Cochlear Implant, Virtual Reality, Children, Teenagers, Deaf, Bilateral, Training, Rehabilitation
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Both EARS training package (BEARS)Other
The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. Each game is based on an audio-visual task performed through a virtual-reality interface. Players are guided through on-screen visual prompts to support the gameplay with feedback given on their performance and progress through levels of increasing difficulty. The BEARS training package design allows for the training to be self-administered, played anywhere and at any time. There is no upper limit to the frequency of use of the BEARS training package, it is advised to play the games for a minimum of 1 hour a week over a minimum of 2x 30-minute sessions, all three games will need to be played.
Usual CareOther
This is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or be cochlear remote care checks. As a minimum this review will check the following: Microphone covers changed, Reported or recorded device use, all external and internal equipment working (known through no reported or recorded degradation in hearing ability). During the appointment, the clinician would establish if there were any concerns regarding the cochlear implant functioning and the patient's rehabilitation programme. They will then make any repairs or adjustments to the device and manage additional support and contact as required. Between the annual review appointments patients can attend the implant centre for repair appointments or have spare equipment posted. There is no limit to the level of contact between the patient and the implant centre.
| Study group | Role | What they receive |
|---|---|---|
| Both EARS training package (BEARS) and Usual Care | Experimental | BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones. Receives: Other: Both EARS training package (BEARS); Other: Usual Care |
| Usual Care | Active comparator | Usual care describes the routine rehabilitation received by participants via their implant centre. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
The Primary outcome for the BEARS trial is the difference between the intervention groups in speech-in-noise perception score (% correct overall task) at 3 months, accounting for the participant's baseline score. This is derived from the spatial speech in noise (SSiN-VA) test.
Measured: Three months
Secondary outcomes (12)
SSiN-VA test outcome
Speech-in-noise perception score (% correct of the overall task) at twelve months accounting for the baseline score.
Measured: Twelve months
SSiN-VA test outcome
Relative localisation score (% correct) at three months and at twelve months accounting for the baseline score.
Measured: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Speech reception threshold at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
Measured: Three and Twelve Months
British Picture Vocabulary Scale (BPVS) test outcome
Difference between arms in vocabulary age at twelve months, accounting for baseline vocabulary age
Measured: Twelve Months
Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
Difference between arms in listening-related fatigue score at three and 12 months, accounting for baseline.
Measured: Three and Twelve Months
Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome
Difference between arms in SSQ scores at three and 12 months, accounting for baseline.
Measured: Three and Twelve Months
Health Economic outcomes
The economic evaluation will calculate incremental cost per quality-adjusted life-year (QALY) gained by offering BEARS and usual care, compared to usual care, from an NHS, Personal Social Services (PSS) and Local Education Provider perspective over the twelve months of the trial.
Measured: Twelve Months
SSiN-VA test outcome
Average reaction time (measure of listening effort) for word identification selections at three months and at twelve months accounting for the baseline score.
Measured: Three and Twelve Months
SSiN-VA test outcome
Average reaction time (measure of listening effort) for location shift selection at three months, and at twelve months accounting for the baseline score.
Measured: Three and Twelve Months
SSiN-VA test outcome
Spatial index for word identification at three months and at twelve months accounting for the baseline score.
Measured: Three and Twelve Months
SSiN-VA test outcome
Spatial index for relative localisation at three months and at twelve months accounting for the baseline score.
Measured: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Spatial release from masking score at three months and at twelve months, accounting for baseline (for better ear, worse ear, and average of both).
Measured: Three and Twelve Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start27 Jul 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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 Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Parallel groups
- Model description
- Participants will be randomised on a 1:1 ratio to either the BEARS or usual care intervention arm. The trial will be unblinded.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University College, London, Imperial College London, University of Nottingham, Cambridge University Hospitals NHS Foundation Trust, University of Southampton, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808543
- Sponsor's protocol ID
- 319903
- Acronym
- BEARS
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vickers D, Salorio-Corbetto M, Driver S, Rocca C, Levtov Y, Sum K, Parmar B, Dritsakis G, Albanell Flores J, Jiang D, Mahon M, Early F, Van Zalk N, Picinali L. Involving Children and Teenagers With Bilateral Cochlear Implants in the Design of the BEARS (Both EARS) Virtual Reality Training Suite Improves Personalization. Front Digit Health. 2021 Nov 12;3:759723. doi: 10.3389/fdgth.2021.759723. eCollection 2021.
PubMed 34870270Salorio-Corbetto M, Williges B, Lamping W, Picinali L, Vickers D. Evaluating Spatial Hearing Using a Dual-Task Approach in a Virtual-Acoustics Environment. Front Neurosci. 2022 Mar 8;16:787153. doi: 10.3389/fnins.2022.787153. eCollection 2022.
PubMed 35350560
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants
- ClinicalTrials.gov ID
- NCT05808543
- Acronym / sponsor ID
- BEARS / 319903
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Deafness, Hearing Impaired Children and Adolescents
- Keywords
- Cochlear Implant, Virtual Reality, Children, Teenagers, Deaf, Bilateral, Training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, University College, London, Imperial College London, University of Nottingham, Cambridge University Hospitals NHS Foundation Trust, University of Southampton, National Institute for Health Research, United Kingdom
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Apr 2023 (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 goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants.
The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.
Detailed description
Deafness is the most frequent human sensory deficit. Cochlear implantation is the primary intervention. Currently over 6000 people have bilateral cochlear implants in the United Kingdom, most of these are children.
Two implants are supposed to provide better access to sound, but it is challenging to interpret and integrate what is heard from both sides. Our 'Living with cochlear implants' Patient and Public Involvement group reported that everyday communication is challenging and tiring, with extra effort required to integrate information from two ears, especially in noise. They reported that current rehabilitation techniques are not engaging, or appropriate to their lifestyles.
To address these issues, we have developed a set of virtual reality games called BEARS (Both EARS). BEARS trains sound localisation and listening in noise. These are skills required in everyday listening.
The aim of this trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants. The study will be carried out in clinical cochlear implant departments in National Health Service or University hospitals.
Participants will be randomly allocated into one of two groups:
- Receiving the BEARS training package to use for 3-months alongside usual care
- Continue with usual care
The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.
Participants and clinicians can also consent to qualitative or process evaluation interviews, which are BEARS sub-studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised on a 1:1 ratio to either the BEARS or usual care intervention arm. The trial will be unblinded.
| Arm | Type | Receives |
|---|---|---|
| Both EARS training package (BEARS) and Usual Care | Experimental | Other: Both EARS training package (BEARS), Other: Usual CareBEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones. |
| Usual Care | Active comparator | Other: Usual CareUsual care describes the routine rehabilitation received by participants via their implant centre. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
- Participant has stable programmes (defined as no longer using progressive programmes to work through).
- Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.
- Participant is aged 8-16 years, inclusive.
Key exclusion criteria (13 listed)
- Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments.
- Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.
- Participant has a comorbid condition impacting ability to participate in the intervention and/or outcome assessment.
- Participant has an audiological profile impacting ability to participate in the intervention and/or outcome assessments.
- Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.
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 |
|---|---|---|
| Both EARS training package (BEARS)The BEARS training package comprises of three games addressing different hearing functions: speech-in-noise perception, music listening and sound-source localisation. Each game is based on an audio-visual task performed through a virtual-reality interface. Players are guided through on-screen visual prompts to support the gameplay with feedback given on their performance and progress through levels of increasing difficulty. The BEARS training package design allows for the training to be self-administered, played anywhere and at any time. There is no upper limit to the frequency of use of the BEARS training package, it is advised to play the games for a minimum of 1 hour a week over a minimum of 2x 30-minute sessions, all three games will need to be played. | Other | Both EARS training package (BEARS) and Usual Care |
| Usual CareThis is an annual review appointment with the patient and their clinician. This could be face-to-face, virtual video consultation, questionnaire, or be cochlear remote care checks. As a minimum this review will check the following: Microphone covers changed, Reported or recorded device use, all external and internal equipment working (known through no reported or recorded degradation in hearing ability). During the appointment, the clinician would establish if there were any concerns regarding the cochlear implant functioning and the patient's rehabilitation programme. They will then make any repairs or adjustments to the device and manage additional support and contact as required. Between the annual review appointments patients can attend the implant centre for repair appointments or have spare equipment posted. There is no limit to the level of contact between the patient and the implant centre. | Other | Both EARS training package (BEARS) and Usual Care, Usual Care |
Primary outcome
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome
Time frame: Three months
The Primary outcome for the BEARS trial is the difference between the intervention groups in speech-in-noise perception score (% correct overall task) at 3 months, accounting for the participant's baseline score. This is derived from the spatial speech in noise (SSiN-VA) test.
12 secondary outcomes
SSiN-VA test outcome
Time frame: Twelve months
SSiN-VA test outcome
Time frame: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Time frame: Three and Twelve Months
British Picture Vocabulary Scale (BPVS) test outcome
Time frame: Twelve Months
Vanderbilt Fatigue Scale: Child self-report version (VFS-C) questionnaire outcome
Time frame: Three and Twelve Months
Speech, Spatial, and Qualities of Hearing Scale for Children with Impaired Hearing (SSQ) outcome
Time frame: Three and Twelve Months
Health Economic outcomes
Time frame: Twelve Months
SSiN-VA test outcome
Time frame: Three and Twelve Months
SSiN-VA test outcome
Time frame: Three and Twelve Months
SSiN-VA test outcome
Time frame: Three and Twelve Months
SSiN-VA test outcome
Time frame: Three and Twelve Months
Spatial Adaptive Sentence List (Sp-ASL) test outcomes
Time frame: Three and Twelve Months
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 1 Apr 2026.
- Results publication: PubMed 34870270Vickers D, Salorio-Corbetto M, Driver S, Rocca C, Levtov Y, Sum K, Parmar B, Dritsakis G, Albanell Flores J, Jiang D, Mahon M, Early F, Van Zalk N, Picinali L. Involving Children and Teenagers With Bilateral Cochlear Implants in the Design of the BEARS (Both EARS) Virtual Reality Training Suite Improves Personalization. Front Digit Health. 2021 Nov 12;3:759723. doi: 10.3389/fdgth.2021.759723. eCollection 2021.
- Results publication: PubMed 35350560Salorio-Corbetto M, Williges B, Lamping W, Picinali L, Vickers D. Evaluating Spatial Hearing Using a Dual-Task Approach in a Virtual-Acoustics Environment. Front Neurosci. 2022 Mar 8;16:787153. doi: 10.3389/fnins.2022.787153. eCollection 2022.
- BEARS websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Liz Arram, MSc contact
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Both EARS training package (BEARS) in people with Hearing Loss, Sensorineural and Hearing Loss, run by Guy's and St Thomas' NHS Foundation Trust at 13 sites in United Kingdom.
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 6 inclusion and 13 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. 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 Debi Vickers, PhD (01223 760683, dav1000@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial speech in Noise - Virtual Acoustics (SSiN-VA) test outcome (time frame: Three months). 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 NCT05808543, 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 1 Apr 2026.