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Hearing LossNCT03157492

Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

A study testing Aural Rehabilitation Group and Cognitive Training Group in people with Hearing Loss and Deafness, run by Gallaudet University at 5 sites 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 evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. Half the participants will receive aural rehabilitation and the other half cognitive training. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss, Deafness
What is being tested?
Aural Rehabilitation Group and Cognitive Training Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
5 sitesUnited States
Study dates
2 May 2017to 13 Oct 2021
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

  • Speech Tracking rate of at least 20 words per minute
  • Sentence recognition scores (CasperSent) between 10% and 85%
  • Passing score on cognitive screener (Callahan et al., 2002)

Who cannot join

  • Less than 18 years of age
  • Pre-lingually deafened
  • Prior Aural Rehabilitation with cochlear implant
  • Greater than three years post-activation of CI

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Maryland

    College Park, Maryland, 20742

  • Columbia University

    New York, New York, 10032

  • University of South Florida

    Tampa, Florida, 33620-8150

  • Gallaudet University

    Washington D.C., District of Columbia, 20002

Other trials in United States

About this study

Official title: Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

This study evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. Half the participants will receive aural rehabilitation and the other half cognitive training. The hypothesis is that short-term aural rehabilitation via telerehab technology will improve outcomes for post-lingually deafened cochlear implant users

Read the detailed description

Aural rehabilitation training (AR) has been demonstrated to improve outcomes for adult cochlear implant users. There are both financial and non-financial barriers to AR service delivery including accessibility (mobility, distance and transportation problems), accommodation (time off work impossible, caring for family) and availability (limited providers in rural areas, financial constraints, and lack of transportation. In this study the investigators will measure the impact of telerehab delivery on optimizing speech recognition, communication function, goals, social participation and hearing handicap.

Twenty-four participants will be randomly assigned to one of two treatment groups: aural rehabilitation (AR) and cognitive training (CT). Participants will complete six 90-minute treatment sessions in their home or office via a telerehab platform. Participants will come to a center for three 90-minute assessment sessions: pre-treatment, 1 week, and 2 months post-treatment.

Being tested
Aural Rehabilitation Group, Cognitive Training Group
Keywords
Adult, Post-lingual, Auditory training, Communication strategies, Speech tracking, Speech recognition, Quality of Life
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.

  • Aural Rehabilitation GroupBehavioural

    Participants will complete sessions in their home or office via the internet. Sessions will include listening activities, informational counseling and communication strategies training. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with a cochlear implant.

  • Cognitive Training GroupBehavioural

    The Cognitive Training Group will receive six 90-minute sessions including training exercises (Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Difference) to improve speed and accuracy. Three assessment sessions are also required.

Study groups in NCT03157492
Study groupRoleWhat they receive
Aural Rehabilitation GroupExperimentalThe AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.
Receives: Behavioral: Aural Rehabilitation Group
Cognitive Training GroupSham comparatorThe Cognitive Training Group will receive six 90-minute sessions including training exercises (Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Difference) to improve speed and accuracy.
Receives: Behavioral: Cognitive Training Group

What is being measured

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

  1. Change in Sentence Recognition CasperSent (Boothroyd, 2008)

    Percent correct scores on CasperSent topic-related recorded sentences.

    Measured: Pre-training, One-week and Two-months post-training

Secondary outcomes (4)

  1. Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)

    Participant rates hearing ability and degree of change due to treatment for three self- selected listening situations most important to them.

    Measured: Pre-training, One-week and Two-months post-training

  2. Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)

    Participant rates 25 statements as true Always, Sometimes, or Never. Two subscales are Emotional and Social/situational.

    Measured: Pre-training, One-week and Two-months post-training

  3. Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996

    Participant rates change statements of change post-treatment.

    Measured: One-week and Two-months post-training

  4. Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)

    60-item questionnaire with three domains: Physical, Social and Psychological.

    Measured: Pre-training, One-week and Two-months post-training

Timeline

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

  1. First posted17 May 2017
  2. Study start2 May 2017
  3. Primary completion13 Oct 2021
  4. Study completion13 Oct 2021

Resources

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
Model description
Participants are randomly assigned to either AR Treatment or Active (Cognitive Training) Control Group. Participants are not told they are in the control group. After the final assessment (two-month post-treatment), control group participants are offered the AR treatment.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157492
Sponsor's protocol ID
2508
Other IDs
90RE5020
Status last verified
Oct 2021
First submitted
15 May 2017
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boothroyd, A. CasperSent: A program for computer-assisted speech perception testing and training at the sentence level. J Am Acad Rehab Audiol. 2008;41:30-50.

  • Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.

    PubMed 12218768

  • Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.

    PubMed 9046067

  • Hinderink JB, Krabbe PF, Van Den Broek P. Development and application of a health-related quality-of-life instrument for adults with cochlear implants: the Nijmegen cochlear implant questionnaire. Otolaryngol Head Neck Surg. 2000 Dec;123(6):756-65. doi: 10.1067/mhn.2000.108203.

    PubMed 11112975

  • Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):415-22. doi: 10.1177/000348949610500601.

    PubMed 8638891

  • Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982 May-Jun;3(3):128-34. doi: 10.1097/00003446-198205000-00006.

    PubMed 7095321

Questions about this trial

What is this clinical trial studying?

A study testing Aural Rehabilitation Group and Cognitive Training Group in people with Hearing Loss and Deafness, run by Gallaudet University at 5 sites 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 3 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

Change in Sentence Recognition CasperSent (Boothroyd, 2008) (time frame: Pre-training, One-week and Two-months post-training). 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 NCT03157492, which also lists 6 linked publications.

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 14 Oct 2021.

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