NCT02294812

Brief 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. The investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

November 3, 2014

Last Update Submit

January 26, 2021

Conditions

Keywords

Hearing LossSpeech PerceptionCognitive TrainingCognitive FitnessMemory, Short-Term

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Weeks 2, 10, and 18

Secondary Outcomes (3)

  • Working Memory Cognitive Training - Improvements in working memory abilities from baseline

    Weeks 2, 10, and 18

  • Brain Performance Test

    Weeks 2 and 10

  • Attention Cognitive Training - Improvements in attention abilities from baseline

    Weeks 2, 10, and 18

Study Arms (3)

Control, cognitive training

ACTIVE COMPARATOR

Participants in the control arm will receive cognitive training for cognitive abilities not affected by age-related hearing loss.

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.

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.

Behavioral: Cognitive training

Interventions

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.

Active Control, crossword trainingControl, cognitive trainingExperimental, cognitive training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroCognitive Imaging Lab, Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Related Links

MeSH Terms

Conditions

Hearing LossDeafness

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aaron J Newman, PhD

    Dalhousie University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neuropsychologist

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 19, 2014

Study Start

September 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations