CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Primary Purpose
Hearing Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naida Link CROS
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impairment
Eligibility Criteria
Inclusion Criteria:
- Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
- Ages 65+ years and above
- At least 6 months of CI use experience
- Current users of a Naida CI Q70 or Q90 processor
- Do not currently use a Naida Link CROS device
- Limited usable/aidable hearing in the contralateral ear
- Fluent in spoken English
- Willingness to use the CROS device regularly for the study duration
- Willingness to follow-up on a biweekly/monthly basis
Exclusion Criteria:
- < 6 months of CI use experience
- < 30% sentence recognition scores in quiet with unilateral CI
- Inability to participate in speech testing
- Inability to follow and complete questionnaires
- Inability to designate an FC
- not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants
Sites / Locations
- University of Utah Heath
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Naida Link CROS device
Arm Description
Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
Outcomes
Primary Outcome Measures
Higher Speech Understanding
Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions
Secondary Outcome Measures
Increased Quality of Life
Use of the CROS device will lead to positive changes in ratings on Quality of Life measures(using Auditory Performance and Satisfaction Scale for Single-Sided Deafness (APS-SSD) for unilateral CI recipients and their frequent communication partners. This scale asks participants to choose between a range of 0(Good Function) to 6(cannot function at all).
Full Information
NCT ID
NCT04794179
First Posted
February 1, 2019
Last Updated
September 27, 2021
Sponsor
University of Utah
Collaborators
Advanced Bionics
1. Study Identification
Unique Protocol Identification Number
NCT04794179
Brief Title
CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Official Title
CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Advanced Bionics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of the Naida Link CROS device on speech understanding in challenging listening situations and on the quality of life in unilateral CI recipients and their frequent communication partners. We hypothesize that:
Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners
A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week.
Detailed Description
Cochlear Implants (CI) are now a well-accepted treatment for individuals with severe to profound hearing impairment. Compared to using one CI, bilateral CIs are known to provide access to some of the benefits of binaural hearing like improved speech understanding in noise (primarily due to headshadow), improved localization, reduced stress and fatigue, and improved quality of life (e.g., Dunn et al. 2012, Litovsky et al. 2012, Härkönen et al. 2016, Reeder et al. 2014, Agrawal 2008). However, a number of CI recipients are unable to or choose not to be implanted bilaterally for many reasons. Those with acoustic hearing in the contralateral ear can benefit significantly by using a hearing aid in that ear (bimodal hearing) (Ching et el. 2006, Dorman and Gifford 2010, Dorman et al. 2015, Dunn et al. 2005, Firszt et al. 2012, Illg et al. 2014, Farinetti et al. 2015).
Unilateral CI recipients do not have access to advantages of bilateral and bimodal hearing. In addition to reduced speech understanding in noise, especially when the speech source is located towards the non-CI, they can also experience increased stress and fatigue. Studies have shown that a CROS device, when worn on the contralateral, non-implanted ear, can help overcome speech understanding deficits due to head-shadow. The effect of such technology on quality of life of the CI recipient and their frequent communication partners has not been evaluated over an extended duration of use.
Study methodology:
Fifteen unilateral CI recipients will participate in this study. Testing will be conducted at the University of Utah Hospital ENT clinic. The study will comprise of 2 clinic visits separated by a take-home phase of 6 months. A designated FCP will be a part of each study visit, preferably.
Following are the test measures for CI recipients:
Questionnaires
Data logs
Pure-tone audiometry
Speech intelligibility
Following are the test measures for FCPs:
• Questionnaires
Speech testing will be conducted in a sound booth with a two speaker set-up (± 90°). AZBio sentences (Spahr et al., 2012) presented at 65 dB A will be the target stimuli. The interferer will be a multi-talker babble. The babble will be presented at an individualized level for each participant where their performance in noise in SCROS(Off)NCI configuration is half of their performance in quiet in SCROS(Off) configuration.
Study devices: For speech testing in the sound booth, a study Naida CI Q90 sound processor will be used. For the take-home phase, recipients will use their own Naida CI processor (Q70 or Q90). A Naida Link CROS will also be used for sound-booth testing as well as the take-home phase.
Workflow:
After recruiting, following will be mailed to the participants to be completed prior to the study visit and hand carried to visit 1:
For each CI subject:
(i) Informed consent form (ii) APS-SSD (Schafer et al, 2013, modified by H. Snapp, 2017) (iii) Nijmegen questionnaire (adapted from Hinderink et al, 2000)
For each CI subject's frequent communication partner:
(i) Informed consent form (ii) SOS-HEAR
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naida Link CROS device
Arm Type
Other
Arm Description
Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
Intervention Type
Device
Intervention Name(s)
Naida Link CROS
Intervention Description
Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
Primary Outcome Measure Information:
Title
Higher Speech Understanding
Description
Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Increased Quality of Life
Description
Use of the CROS device will lead to positive changes in ratings on Quality of Life measures(using Auditory Performance and Satisfaction Scale for Single-Sided Deafness (APS-SSD) for unilateral CI recipients and their frequent communication partners. This scale asks participants to choose between a range of 0(Good Function) to 6(cannot function at all).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
Ages 65+ years and above
At least 6 months of CI use experience
Current users of a Naida CI Q70 or Q90 processor
Do not currently use a Naida Link CROS device
Limited usable/aidable hearing in the contralateral ear
Fluent in spoken English
Willingness to use the CROS device regularly for the study duration
Willingness to follow-up on a biweekly/monthly basis
Exclusion Criteria:
< 6 months of CI use experience
< 30% sentence recognition scores in quiet with unilateral CI
Inability to participate in speech testing
Inability to follow and complete questionnaires
Inability to designate an FC
not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gurgel, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Heath
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Agrawal S. (2008) Spatial hearing abilities in adults with bilateral cochlear implants. PhD diss., University of Wisconsin-Madison.
Results Reference
background
PubMed Identifier
17063004
Citation
Ching TY, Incerti P, Hill M, van Wanrooy E. An overview of binaural advantages for children and adults who use binaural/bimodal hearing devices. Audiol Neurootol. 2006;11 Suppl 1:6-11. doi: 10.1159/000095607. Epub 2006 Oct 6.
Results Reference
background
PubMed Identifier
25285624
Citation
Dorman MF, Cook S, Spahr A, Zhang T, Loiselle L, Schramm D, Whittingham J, Gifford R. Factors constraining the benefit to speech understanding of combining information from low-frequency hearing and a cochlear implant. Hear Res. 2015 Apr;322:107-11. doi: 10.1016/j.heares.2014.09.010. Epub 2014 Oct 5.
Results Reference
background
PubMed Identifier
20874053
Citation
Dorman MF, Gifford RH. Combining acoustic and electric stimulation in the service of speech recognition. Int J Audiol. 2010 Dec;49(12):912-9. doi: 10.3109/14992027.2010.509113. Epub 2010 Sep 27.
Results Reference
background
PubMed Identifier
16197280
Citation
Dunn CC, Tyler RS, Witt SA. Benefit of wearing a hearing aid on the unimplanted ear in adult users of a cochlear implant. J Speech Lang Hear Res. 2005 Jun;48(3):668-80. doi: 10.1044/1092-4388(2005/046).
Results Reference
background
PubMed Identifier
22846635
Citation
Dunn CC, Tyler RS, Witt S, Ji H, Gantz BJ. Sequential bilateral cochlear implantation: speech perception and localization pre- and post-second cochlear implantation. Am J Audiol. 2012 Dec;21(2):181-9. doi: 10.1044/1059-0889(2012/12-0004). Epub 2012 Jul 30.
Results Reference
background
PubMed Identifier
25373837
Citation
Farinetti A, Roman S, Mancini J, Baumstarck-Barrau K, Meller R, Lavieille JP, Triglia JM. Quality of life in bimodal hearing users (unilateral cochlear implants and contralateral hearing aids). Eur Arch Otorhinolaryngol. 2015 Nov;272(11):3209-15. doi: 10.1007/s00405-014-3377-8. Epub 2014 Nov 6.
Results Reference
background
PubMed Identifier
22441359
Citation
Firszt JB, Holden LK, Reeder RM, Cowdrey L, King S. Cochlear implantation in adults with asymmetric hearing loss. Ear Hear. 2012 Jul-Aug;33(4):521-33. doi: 10.1097/AUD.0b013e31824b9dfc.
Results Reference
background
PubMed Identifier
25677966
Citation
Harkonen K, Kivekas I, Rautiainen M, Kotti V, Sivonen V, Vasama JP. Sequential bilateral cochlear implantation improves working performance, quality of life, and quality of hearing. Acta Otolaryngol. 2015 May;135(5):440-6. doi: 10.3109/00016489.2014.990056. Epub 2015 Feb 13.
Results Reference
background
PubMed Identifier
25058838
Citation
Illg A, Bojanowicz M, Lesinski-Schiedat A, Lenarz T, Buchner A. Evaluation of the bimodal benefit in a large cohort of cochlear implant subjects using a contralateral hearing aid. Otol Neurotol. 2014 Oct;35(9):e240-4. doi: 10.1097/MAO.0000000000000529.
Results Reference
background
PubMed Identifier
22668767
Citation
Litovsky RY, Goupell MJ, Godar S, Grieco-Calub T, Jones GL, Garadat SN, Agrawal S, Kan A, Todd A, Hess C, Misurelli S. Studies on bilateral cochlear implants at the University of Wisconsin's Binaural Hearing and Speech Laboratory. J Am Acad Audiol. 2012 Jun;23(6):476-94. doi: 10.3766/jaaa.23.6.9.
Results Reference
background
PubMed Identifier
24686778
Citation
Reeder RM, Firszt JB, Holden LK, Strube MJ. A longitudinal study in adults with sequential bilateral cochlear implants: time course for individual ear and bilateral performance. J Speech Lang Hear Res. 2014 Jun 1;57(3):1108-26. doi: 10.1044/2014_JSLHR-H-13-0087.
Results Reference
background
PubMed Identifier
21829134
Citation
Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
Results Reference
background
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CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
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