Hearing LossNCT02294812
Effects of Cognitive Training on Speech Perception
A study testing Cognitive training in people with Hearing Loss and Deafness and Auditory Perception, run by Aaron Newman at 1 site in Canada.
Trial summary
In this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. Individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hearing Loss, Deafness and Auditory Perception
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Sep 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to come to Dalhousie University, Halifax, Nova Scotia, Canada for study visits
- Adults (50 years or older) with mild to moderate hearing loss
- Access to an internet-connected device that is able to use Flash media, basic computer skills
- Medically stable participants
- Not currently taking medication that may affect brain function (e.g., anti-anxiety medication)
- Normal or corrected-to-normal vision
Who cannot join
- Participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons
- Participants who are not native English speakers (materials used in the study are only in English)
- Participants who are unable to provide consent
- Participants with impaired cognition (assessed with the Montreal Cognitive Assessment)
- Participants with high accuracy on the Speech Perception in Noise task at the second study visit (to eliminate participants who may be performing at ceiling level)
Trial locations and contacts
1 site in 1 country.
Canada1 site
NeuroCognitive Imaging Lab, Dalhousie University
Halifax, Nova Scotia, B3H 4R2
About this study
Official title: Effects of Cognitive Training on Age-Related Hearing Loss and Speech Perception
In this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. Individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. The investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.
- Conditions
- Hearing Loss, Deafness and Auditory Perception
- Being tested
- Cognitive training
- Keywords
- Hearing Loss, Speech Perception, Cognitive Training, Cognitive Fitness, Memory, Short-Term
- 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.
Cognitive trainingBehavioural
Participants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory.
Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit.
After eight weeks, participants will no longer partake in training.
| Study group | Role | What they receive |
|---|---|---|
| Control, cognitive training | Active comparator | Participants in the control arm will receive cognitive training for cognitive abilities not affected by age-related hearing loss. Receives: Behavioral: Cognitive training |
| Experimental, cognitive training | Experimental | Participants in the experimental arm will receive cognitive training for cognitive abilities affected by age-related hearing loss. Receives: Behavioral: Cognitive training |
| Active Control, crossword training | Active comparator | Participants in this group will undergo crossword puzzle training. The purpose of this group is control for any effects that may be due to engaging in cognitive training. Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences
Sentences of high predictability and low predictability are played with multi-user talker babble. Participants must repeat the last word of each sentence as they heard it. The primary outcome measure will be the accuracy for repeating the sentence.
Measured: Baseline, Weeks 2, 10, and 18
Secondary outcomes (3)
Working Memory Cognitive Training - Improvements in working memory abilities from baseline
Individuals are asked to participate in 20 hours of cognitive training that will focus on either improving abilities affected by hearing loss (i.e., verbal working memory), or abilities not affected by hearing loss (i.e., spatial working memory).
Performance on the working memory task, Operation Span Task (OSPAN), will be assessed using the total score which is calculated as a sum based on the number of correct answers (letters accurately sequentially recalled) within a block for the duration of the task. Higher scores indicate better working memory capacity. Performance on the working memory cognitive training games will be assessed using the participant's accuracy, reaction time, and final score on the game.
Improvements in working memory will be assessed by comparing participant performance on working memory tasks (OSPAN; cognitive training memory games) before receiving cognitive training, immediately after receiving cognitive training, and eight weeks post-training.
Measured: Weeks 2, 10, and 18
Brain Performance Test
The Brain Performance Test (BPT) is an assessment tool available online through the training program website. Participants will be assessed at home on their initial performance for a variety of cognitive abilities including stop-signal tasks, grammatical reasoning, and memory spans. After completing the eight weeks of cognitive training, participants will again be assessed at home with the BPT to determine whether there are any improvements in cognitive abilities.
Measured: Weeks 2 and 10
Attention Cognitive Training - Improvements in attention abilities from baseline
Individuals are asked to participate in 20 hours of cognitive training. Cognitive training will focus on either improving abilities affected by hearing loss (i.e., attention), or abilities not affected by hearing loss (i.e., spatial working memory).
Performance on the attention task, Flanker-Simon, will be assessed based on participant's accuracy and reaction time for the Flanker task, and the Simon task.
Performance on the attention cognitive training games will be assessed using the participant's accuracy, reaction time, and final score on the game.
Improvements in attention will be assessed by comparing the performance of participants on attention tasks (Flanker-Simon; cognitive training attention games) before receiving cognitive training, immediately after receiving cognitive training, and eight weeks post-training.
Measured: Weeks 2, 10, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startSep 2016
- Primary completionSep 2020
- Study completionSep 2020
Why it stopped: lack of funding and staff to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Newman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Newman, Nova Scotia Health Authority
- Investigators
- Aaron J Newman, PhD, Principal investigator, Dalhousie University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294812
- Sponsor's protocol ID
- NCIL-HL-CT
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2014
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Training on Age-Related Hearing Loss and Speech Perception
- ClinicalTrials.gov ID
- NCT02294812
- Acronym / sponsor ID
- NCIL-HL-CT
- Conditions
- Hearing Loss, Deafness and Auditory Perception
- Keywords
- Hearing Loss, Speech Perception, Cognitive Training, Cognitive Fitness, Memory, Short-Term
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding and staff to conduct the study
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aaron NewmanUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 19 Nov 2014 (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.
In this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. Individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. The investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control, cognitive training | Active comparator | Behavioral: Cognitive trainingParticipants in the control arm will receive cognitive training for cognitive abilities not affected by age-related hearing loss. |
| Experimental, cognitive training | Experimental | Behavioral: Cognitive trainingParticipants in the experimental arm will receive cognitive training for cognitive abilities affected by age-related hearing loss. |
| Active Control, crossword training | Active comparator | Behavioral: Cognitive trainingParticipants in this group will undergo crossword puzzle training. The purpose of this group is control for any effects that may be due to engaging in cognitive training. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to come to Dalhousie University, Halifax, Nova Scotia, Canada for study visits
- Adults (50 years or older) with mild to moderate hearing loss
- Access to an internet-connected device that is able to use Flash media, basic computer skills
- Medically stable participants
- Not currently taking medication that may affect brain function (e.g., anti-anxiety medication)
Key exclusion criteria (5 listed)
- Participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons
- Participants who are not native English speakers (materials used in the study are only in English)
- Participants who are unable to provide consent
- Participants with impaired cognition (assessed with the Montreal Cognitive Assessment)
- Participants with high accuracy on the Speech Perception in Noise task at the second study visit (to eliminate participants who may be performing at ceiling level)
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 |
|---|---|---|
| Cognitive trainingParticipants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory. Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit. After eight weeks, participants will no longer partake in training. | Behavioural | Active Control, crossword training, Control, cognitive training, Experimental, cognitive training |
Primary outcome
Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences
Time frame: Baseline, Weeks 2, 10, and 18
Sentences of high predictability and low predictability are played with multi-user talker babble. Participants must repeat the last word of each sentence as they heard it. The primary outcome measure will be the accuracy for repeating the sentence.
3 secondary outcomes
Working Memory Cognitive Training - Improvements in working memory abilities from baseline
Time frame: Weeks 2, 10, and 18
Brain Performance Test
Time frame: Weeks 2 and 10
Attention Cognitive Training - Improvements in attention abilities from baseline
Time frame: Weeks 2, 10, and 18
Results and safety
The study was stopped early (reason given: lack of funding and staff to conduct the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- NeuroCognitive Imaging LabLink provided by the sponsor.
- 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.
Aaron J Newman, PhD principal investigator
Dalhousie University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Hearing Loss and Deafness and Auditory Perception, run by Aaron Newman at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 27 Jan 2021. 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 Canada. 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 was stopped early (reason given: lack of funding and staff to conduct the study). Results are not available in the source record.
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?
Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences (time frame: Baseline, Weeks 2, 10, and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.