Bilateral Hearing LossNCT00763243

Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants

A study testing Cogmed Working Memory Training Program in people with Bilateral Hearing Loss, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is an investigation of the effect of a computer-based working memory training program on memory and language processing in at-risk children (e.g., those with working memory weaknesses) who have received cochlear implants. Read more about this study

Who is it for?: Ages 7 to 16 years
Conditions the study is for: Bilateral Hearing Loss
What is being tested?: Cogmed Working Memory Training Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Feb 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

age 7-16 years at the time of study enrollment,
profound bilateral hearing loss (> 90 dB HL in the better hearing ear),
implantation prior to age 3 years,
use of multichannel CI's,
a monolingual English home environment,
enrollment in an aural rehabilitative program that encourages the development of speaking and listening skills,

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educational environment that uses oral or total communication (TC) strategies,
sufficient speech perception and language competence to complete basic word and sentence repetition tasks,
no significant developmental delay or neurological condition that, in the opinion of the investigators, would interfere markedly with cognitive functioning,
Windows-based PC at home capable of running Cogmed working memory training software,
mild or greater deficit in working memory, as shown by either (a) a Behavior Rating Inventory of Executive Function (BRIEF) working memory T-score of 50 or higher or (b) a Digit Span scaled score of 10 or lower. Subjects will be discontinued if during the study they have any new or changed intervention (including medication) that involves working memory, attention, concentration, or executive functioning.

Who cannot join

Under 7 years or over 16 years of age at time of study entry
Implantation after age 3 years
Bilingual or non-English-speaking home environment
Primary use of American Sign Language (ASL)

Trial locations and contacts

1 site in 1 country.

United States1 site

Riley Hospital for Children
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Read the detailed description

The long-term goal of this research program is to improve speech-language outcomes in prelingually deaf children who receive CIs. The objective of this proposal is to investigate the short-term effects of a novel working memory training program on memory, learning, and speech-language outcomes in children with CIs. The specific hypothesis of this project is that completion of a behaviorally-based training program designed to increase working memory capacity will improve attention, working memory span, and working memory-related speech-language processing in a group of deaf children with CIs. This hypothesis is based on past research demonstrating the efficacy of working memory training programs in improving attention and working memory in children with attention deficits, as well as on past research showing an association between working memory and speech-language outcomes in children with CIs. Knowledge about the effects of working memory training on CI speech-language outcomes will provide a better understanding of the process by which children with CIs learn speech-language following implantation and may offer an entirely new avenue of intervention to improve speech-language outcomes, particularly in deaf children who show limited improvement following implantation.

The specific aims of this study are:

Specific Aim 1: Determine the feasibility and application of a novel, computer-based working memory training program when applied to children with CIs. We hypothesize that children with CIs will show a progression of learning in both auditory and visual working memory during the training program that will mirror that of normal-hearing children.
Specific Aim 2: Determine the effect of the working memory training program on core attention, concentration, and working memory processes of children with CIs. We hypothesize that children with CIs will show improvement on both laboratory-based and parent-report measures of attention, concentration, and working memory processes after working memory training, compared to a baseline period.
Specific Aim 3: Determine the effect of the working memory training program on working memory-related speech-language outcome measures in children with CIs. We hypothesize that children with CIs will show improvement on auditory working memory, verbal naming fluency, and word repetition after training.

Conditions: Bilateral Hearing Loss
Being tested: Cogmed Working Memory Training Program
Keywords: profound bilateral hearing loss with cochlear implants
Medical subject headings: Hearing Loss, Bilateral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cogmed Working Memory Training ProgramBehavioural
Also called Cogmed
The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success.

Study groups in NCT00763243
Study group	Role	What they receive
Cogmed Working Memory Training	Experimental	Cogmed Working Memory Training Program Receives: Behavioral: Cogmed Working Memory Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Measured: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)
This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.
Measured: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)
The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory.
Measured: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Feb 2010

First posted30 Sep 2008 (estimated)
Study startAug 2008
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bilateral Hearing LossStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763243
Sponsor's protocol ID: 0808-01B
Status last verified: Apr 2017
First submitted: 26 Sep 2008
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss

All Bilateral Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants
ClinicalTrials.gov ID: NCT00763243
Acronym / sponsor ID: 0808-01B
Conditions: Bilateral Hearing Loss
Keywords: profound bilateral hearing loss with cochlear implants
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Aug 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 11 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims of this study are:

Specific Aim 1: Determine the feasibility and application of a novel, computer-based working memory training program when applied to children with CIs. We hypothesize that children with CIs will show a progression of learning in both auditory and visual working memory during the training program that will mirror that of normal-hearing children.
Specific Aim 2: Determine the effect of the working memory training program on core attention, concentration, and working memory processes of children with CIs. We hypothesize that children with CIs will show improvement on both laboratory-based and parent-report measures of attention, concentration, and working memory processes after working memory training, compared to a baseline period.
Specific Aim 3: Determine the effect of the working memory training program on working memory-related speech-language outcome measures in children with CIs. We hypothesize that children with CIs will show improvement on auditory working memory, verbal naming fluency, and word repetition after training.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cogmed Working Memory Training	Experimental	Behavioral: Cogmed Working Memory Training ProgramCogmed Working Memory Training Program

Who may qualify

Ages: 7 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

age 7-16 years at the time of study enrollment,
profound bilateral hearing loss (> 90 dB HL in the better hearing ear),
implantation prior to age 3 years,
use of multichannel CI's,
a monolingual English home environment,

Key exclusion criteria (4 listed)

Under 7 years or over 16 years of age at time of study entry
Implantation after age 3 years
Bilingual or non-English-speaking home environment
Primary use of American Sign Language (ASL)

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
Cogmed Working Memory Training ProgramAlso: CogmedThe Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success.	Behavioural	Cogmed Working Memory Training

Primary outcome

Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
Time frame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)
Time frame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.
Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)
Time frame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior "never" (=1), "sometimes" (=2), or "often" (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory.

Results and safety

Results posted to the registry on 11 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cogmed Working Memory Training	9	9

Primary outcome: Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)

Time frame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit). Mean (Standard Deviation). Unit: Scores on a scale

Measure	Screening Visit n = 9	Pretraining Visit n = 9	Posttraining Visit n = 9	1-Month Follow Up Visit n = 9	6-Month Follow Up Visit n = 9
Value	11 (3.28)	11.22 (2.54)	12.89 (2.93)	13 (3.64)	11.56 (2.79)

Screening Visit vs Pretraining Visit: Mean Difference (Final Values): 0.22 (95% CI -1.44 to 1.89), p = 0.766, t-test, 2 sided
Pretraining Visit vs Posttraining Visit: Mean Difference (Final Values): 1.67 (95% CI 0.90 to 2.44), p <0.001, t-test, 2 sided
Pretraining Visit vs 1-Month Follow Up Visit: Mean Difference (Final Values): 1.78 (95% CI 0.35 to 3.20), p = 0.021, t-test, 2 sided

Primary outcome: Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)

Measure	Screening Visit n = 9	Pretraining Visit n = 9	Posttraining Visit n = 9	1-Month Follow Up Visit n = 9	6-Month Follow Up Visit n = 9
Value	13 (2.24)	14.33 (3.35)	16.78 (3.83)	16.44 (4.13)	15.11 (4.26)

Screening Visit vs Pretraining Visit: Mean Difference (Final Values): 1.33 (95% CI -0.39 to 3.05), p = 0.11, t-test, 2 sided
Pretraining Visit vs Posttraining Visit: Mean Difference (Final Values): 2.44 (95% CI 1.05 to 3.84), p = 0.004, t-test, 2 sided
Pretraining Visit vs 1-Month Follow Up Visit: Mean Difference (Final Values): 2.11 (95% CI -0.24 to 4.46), p = 0.072, t-test, 2 sided

Primary outcome: Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)

Measure	Screening Visit n = 9	Pretraining Visit n = 9	Posttraining Visit n = 9	1-Month Follow Up Visit n = 9	6-Month Follow Up Visit n = 9
Value	16.89 (3.92)	17.11 (3.72)	15.33 (3.61)	16.22 (3.93)	16.44 (3.50)

Screening Visit vs Pretraining Visit: Mean Difference (Final Values): 0.22 (95% CI -1.20 to 1.65), p = 0.729, t-test, 2 sided
Pretraining Visit vs Posttraining Visit: Mean Difference (Final Values): -1.78 (95% CI -3.44 to -0.11), p = 0.039, t-test, 2 sided
Pretraining Visit vs 1-Month Follow Up Visit: Mean Difference (Final Values): -0.89 (95% CI -3.17 to 1.40), p = 0.40, t-test, 2 sided

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening Visit	0 of 9 (0%)	0 of 9 (0%)	Not reported
Pretraining Visit	0 of 9 (0%)	0 of 9 (0%)	Not reported
Posttraining Visit	0 of 9 (0%)	0 of 9 (0%)	Not reported
1-Month Follow Up Visit	0 of 9 (0%)	0 of 9 (0%)	Not reported
6-Month Follow Up Visit	0 of 9 (0%)	0 of 9 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bilateral Hearing Loss

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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.

William G. Kronenberger, PhD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cogmed Working Memory Training Program in people with Bilateral Hearing Loss, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory) (time frame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)). The study lists 3 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 NCT00763243.

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 11 Jul 2017.