AphasiaListen-inNCT02540889
Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.
A study testing Auditory comprehension therapy. in people with Aphasia, run by University College, London at 1 site in United Kingdom.
Trial summary
The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen-In will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Auditory comprehension therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2016to 12 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any type of stroke but greater than 6 months post onset
- evidence of receptive aphasia
- English as their main language
- able to give informed consent
- age 18 years or above
- no diagnosis of degenerative brain disease.
Who cannot join
- Stroke less than 6 months post onset
- No evidence of receptive aphasia
- English not their main language
- Unable to give informed consent
- Less than 18 years old
- diagnosis of degenerative brain disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke
The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen-In will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. This will free up therapists time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.
Read the detailed description
The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen In will provide an effective speech comprehension training tool that patients can use to practice independently. This will free up SALT time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.
Phase 1 (24 months. London, Newcastle, Cambridge): Development of Listen In, including diagnostic and therapeutic components, driven by patient user's feedback (alpha and beta testing). The intervention is detailed below and is based on current SALT practice. It will be adaptive, provide feedback and target auditory perception at many levels: the phonemic, lexical and sentence level processing of heard verbal stimuli, as well as auditory short term memory and nonverbal sound discrimination.
Phase 2 (12 months. London and Cambridge): A pilot, randomised, crossover, clinical trial of Listen-In in a group of aphasic patients in the chronic post-stroke period. A power calculation suggests that we will need 36 patents, 18 in each arm. The comparison will be standard SALT clinical care. The main outcome measure is a clinically relevant improvement on the comprehension of spoken language score of the Comprehensive Aphasia Test (Swinburn, 2004). Secondary outcomes include improvements in social activity and participation. The milestones for this phase will be: 50% recruitment into study and last patient, last visit.
Phase 3 (funded outside i4i grant) will be the rollout of the therapy application on the internet with a pragmatic trial of whether therapy gains can be made outside the confines of a clinical trial. The comparison will be on similar outcome measures as Phase 2 with a control test on sustained attention (internal control) that we predict will not improve with therapy.
- Conditions
- Aphasia
- Being tested
- Auditory comprehension therapy.
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory comprehension therapy.Behavioural
100 hours of Auditory comprehension therapy embedded within a computer game.
| Study group | Role | What they receive |
|---|---|---|
| trial arm | Experimental | 100 hours of therapy. Receives: Behavioral: Auditory comprehension therapy. |
| Normal therapy arm | No intervention | 12 weeks of normal therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in auditory comprehension on the comprehensive aphasia test.
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Secondary outcomes (7)
Improvement in functional communication
Using patient reported outcomes to look at functional communication changes.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Improvement in production of language
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Performance on the Sustained attention to response task
Investigation of improvement on sustained attention using the SART.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Environmental sounds test
Investigation of improvement on the non verbal environmental sounds test.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Test of semantics
Investigation of improvement in semantics knowledge.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Improvement in written language comprehension
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Improvement on auditory descrimination
Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.
Measured: Measured over 36 weeks (0,12,24,36) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start16 May 2016
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alex Leff, PhD, Principal investigator, ucl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540889
- Sponsor's protocol ID
- 14/0452
- Acronym
- Listen-in
- Status last verified
- Jul 2017
- First submitted
- 28 Aug 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fleming V, Brownsett S, Krason A, Maegli MA, Coley-Fisher H, Ong YH, Nardo D, Leach R, Howard D, Robson H, Warburton E, Ashburner J, Price CJ, Crinion JT, Leff AP. Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging. J Neurol Neurosurg Psychiatry. 2020 Nov 5;92(4):418-24. doi: 10.1136/jnnp-2020-324256. Online ahead of print.
PubMed 33154182
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke
- ClinicalTrials.gov ID
- NCT02540889
- Acronym / sponsor ID
- Listen-in / 14/0452
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals, Cambridge University Hospitals NHS Foundation Trust
- Study start
- 16 May 2016 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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 main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen-In will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. This will free up therapists time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.
Detailed description
The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen In will provide an effective speech comprehension training tool that patients can use to practice independently. This will free up SALT time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.
Phase 1 (24 months. London, Newcastle, Cambridge): Development of Listen In, including diagnostic and therapeutic components, driven by patient user's feedback (alpha and beta testing). The intervention is detailed below and is based on current SALT practice. It will be adaptive, provide feedback and target auditory perception at many levels: the phonemic, lexical and sentence level processing of heard verbal stimuli, as well as auditory short term memory and nonverbal sound discrimination.
Phase 2 (12 months. London and Cambridge): A pilot, randomised, crossover, clinical trial of Listen-In in a group of aphasic patients in the chronic post-stroke period. A power calculation suggests that we will need 36 patents, 18 in each arm. The comparison will be standard SALT clinical care. The main outcome measure is a clinically relevant improvement on the comprehension of spoken language score of the Comprehensive Aphasia Test (Swinburn, 2004). Secondary outcomes include improvements in social activity and participation. The milestones for this phase will be: 50% recruitment into study and last patient, last visit.
Phase 3 (funded outside i4i grant) will be the rollout of the therapy application on the internet with a pragmatic trial of whether therapy gains can be made outside the confines of a clinical trial. The comparison will be on similar outcome measures as Phase 2 with a control test on sustained attention (internal control) that we predict will not improve with therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial arm | Experimental | Behavioral: Auditory comprehension therapy.100 hours of therapy. |
| Normal therapy arm | No intervention | –12 weeks of normal therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- any type of stroke but greater than 6 months post onset
- evidence of receptive aphasia
- English as their main language
- able to give informed consent
- age 18 years or above
Key exclusion criteria (6 listed)
- Stroke less than 6 months post onset
- No evidence of receptive aphasia
- English not their main language
- Unable to give informed consent
- Less than 18 years old
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 comprehension therapy.100 hours of Auditory comprehension therapy embedded within a computer game. | Behavioural | trial arm |
Primary outcome
Improvement in auditory comprehension on the comprehensive aphasia test.
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
7 secondary outcomes
Improvement in functional communication
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Improvement in production of language
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Performance on the Sustained attention to response task
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Environmental sounds test
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Test of semantics
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Improvement in written language comprehension
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Improvement on auditory descrimination
Time frame: Measured over 36 weeks (0,12,24,36) weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 33154182Fleming V, Brownsett S, Krason A, Maegli MA, Coley-Fisher H, Ong YH, Nardo D, Leach R, Howard D, Robson H, Warburton E, Ashburner J, Price CJ, Crinion JT, Leff AP. Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging. J Neurol Neurosurg Psychiatry. 2020 Nov 5;92(4):418-24. doi: 10.1136/jnnp-2020-324256. Online ahead of print.
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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.
Alex Leff, PhD principal investigator
ucl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory comprehension therapy. in people with Aphasia, run by University College, London at 1 site 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 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in auditory comprehension on the comprehensive aphasia test. (time frame: Measured over 36 weeks (0,12,24,36) weeks). 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 NCT02540889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.