NCT01892007

Brief Summary

A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive) working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in older adults (50-74 years) with mild-moderate hearing loss who are existing hearing aid users, compared with an active placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained Cogmed tasks, representing increased working memory capacity, will result in improved performance on cognitive and speech perception tasks that engage working memory. We also measure self-reported hearing ability to assess self-perceived benefit of Cogmed training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 years until next milestone

Results Posted

Study results publicly available

October 1, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

June 27, 2013

Results QC Date

November 10, 2017

Last Update Submit

September 9, 2020

Conditions

Hearing Loss

Keywords

Hearing lossHearing aidSpeech intelligibilitySpeech perceptionCognitive trainingWorking memoryWorking memory training

Outcome Measures

Primary Outcomes (1)

  • Visual Letter Monitoring Task

    The VLM is a visual task of working memory (Gatehouse, Naylor, \& Elberling, 2006) that is not trained within the Cogmed working memory training program. Ten consonant-vowel-consonant (CVC) words are embedded in an 80-letter sequence. Two sequences are presented to participants at each outcome assessment in a counterbalanced order. Individual letters are displayed sequentially on a computer screen at a rate of 2 second per letter (first list) and 1 second per letter (second list). Participants were asked to press the keyboard 'space bar' (hit) when three consecutive letters formed a recognised CVC word (for example, M-A-T). Task performance was scored as the total number of hits (maximum score of ten per list). Higher scores indicate better performance.

    0, 2, 7, and (adaptive training group only) 31 weeks

Secondary Outcomes (10)

  • Phonemic Discrimination Probe

    0, 2, 7 and (adaptive training group only) 31 weeks

  • BESST High/Low Context Sentence Intelligibility

    0, 2, 7 and (adaptive training group only) 31 weeks

  • Modified Coordinate Response Measure (MCRM)

    0, 2, 7 and (adaptive training group only) 31 weeks

  • Digit Span Backwards

    0, 2, 7 and (adaptive training group only) 31 weeks

  • Test of Attention in Listening (TAIL)

    0, 2, 7 and (adaptive training group only) 31 weeks

  • +5 more secondary outcomes

Study Arms (2)

Cogmed RM (adaptive)

EXPERIMENTAL

Online training intervention: An adaptive version of Cogmed RM working memory training. Task difficulty (number of to-be-remembered items) increases based on individual performance, in order to maintain average daily performance levels of approximately 60% of trials correct. Participants complete 35-45 minutes of active training per day, 5 days a week for 5 weeks.

Behavioral: Cogmed RM - Online adaptive working memory training

Cogmed RM (non-adaptive, placebo)

PLACEBO COMPARATOR

Online training intervention: A non-adaptive placebo version of Cogmed RM working memory training. Tasks are fixed at a low-difficulty practice level (three to-be-remembered items) and do not increase in difficulty over the course of the intervention. Participants complete 35-45 minutes of active placebo training per day, 5 days a week for 5 weeks.

Behavioral: Cogmed RM - Online non-adaptive (placebo) working memory training

Interventions

Cogmed RM - Online adaptive working memory trainingBEHAVIORAL
Cogmed RM (adaptive)
Cogmed RM - Online non-adaptive (placebo) working memory trainingBEHAVIORAL
Cogmed RM (non-adaptive, placebo)

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Existing (3+ months) hearing aid(s) user
  • Mild to moderate (PTA0.25-4k Hz 21-69 dB HL) sensorineural hearing loss (SNHL) in the better hearing ear (SNHL defined as air-bone gap across 0.5k, 1k \& 2k Hz \< 15 dB)
  • Internet access at home

You may not qualify if:

  • Participation in a previous training intervention study
  • First language other than English (all speech outcome measure are presented in English)
  • Unable to use either a desktop or laptop computer (Cogmed RM working memory training is delivered via the internet using a desktop or laptop computer)
  • Cognitive impairment as defined as a score of less than 26/30 (fail) on the Montreal Cognitive Assessment (MoCA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QMC Ropewalk House

Nottingham, Nottinghamshire, NG1 5DU, United Kingdom

Location

Related Publications (2)

  • Henshaw H, Heinrich A, Tittle A, Ferguson M. Cogmed Training Does Not Generalize to Real-World Benefits for Adult Hearing Aid Users: Results of a Blinded, Active-Controlled Randomized Trial. Ear Hear. 2022 May/Jun;43(3):741-763. doi: 10.1097/AUD.0000000000001096.

    PMID: 34524150DERIVED

  • Henshaw H, Ferguson MA. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial. Trials. 2013 Dec 5;14:417. doi: 10.1186/1745-6215-14-417.

    PMID: 24304745DERIVED

MeSH Terms

Conditions

Hearing LossSpeech Intelligibility

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr Helen Henshaw
Organization
NIHR Nottingham Biomedical Research Centre, University of Nottingham
helen.henshaw@nottingham.ac.uk
+44 (0)115 8232606

Study Officials

  • Helen Henshaw, PhD

    NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.

    PRINCIPAL INVESTIGATOR

  • Melanie Ferguson, BSc (Hons)

    NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 3, 2013

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 1, 2020

Results First Posted

October 1, 2020

Record last verified: 2020-09

Locations

GB(1)