Trial record 2 of 137 for:    daniel lee | Open Studies

Cochlear Implantation for Treatment of Single-sided Deafness

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Massachusetts Eye and Ear Infirmary
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT02532972
First received: August 14, 2015
Last updated: January 6, 2016
Last verified: January 2016
  Purpose
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).

Condition Intervention
Total Unilateral Deafness
Unilateral Partial Deafness
Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cochlear Implantation for Treatment of Single-sided Deafness

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Sound field thresholds following cochlear implantation via pure-tone threshold audiometry [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Sound detection via pure-tone threshold audiometry

  • Speech perception following cochlear implantation assessed by word recognition testing [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Identification of stimuli from word and sentence lists

  • Subjective benefit of cochlear implantation assessed by questionnaires [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Qualitative hearing outcomes assessed by questionnaires

  • Sound localization following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Identification of the location for auditory stimuli emitted from one or multiple loudspeakers

  • Speech-in-Noise studies (signal-to-noise ratio) following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Identification of words or sentences in the presence of noise (other speech or auditory stimuli) emitted from one or multiple loudspeakers.


Secondary Outcome Measures:
  • Subjective changes in tinnitus following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Tinnitus severity rated by the Tinnitus Handicap Index (THI)

  • Subjective loudness of tinnitus following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Tinnitus loudness rated by the patient on a 0 - 10 scale

  • Tinnitus level (dB) matching following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Tinnitus loudness measured as the level (in dB) of sound stimulation of the hearing ear needed to match the perceived loudness (in dB) of tinnitus

  • Changes in brainstem activity following cochlear implantation [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]
    Auditory Brainstem Responses (ABR) with monaural sound stimulation of the hearing ear


Estimated Enrollment: 10
Study Start Date: September 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cochlear Implant surgery
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Other Names:
  • CI
  • cochlear implant

Detailed Description:
The goal of this study is to further investigate the role of CI in treating unilateral hearing loss and associated tinnitus. Single-sided deafness (SSD) afflicts approximately 60,000 new patients per year in the United States. The most common causes of these single-sided losses are sudden sensorineural hearing loss, Meniere's disease, trauma, and vestibular schwannoma. Patients with SSD face significant difficulty with communicating in the presence of background noise and in sound localization. Another significant problem for some SSD patients is tinnitus, which can be incapacitating and for which there are no therapies available that are considered to be of sufficient reliability to become a standard of care. Difficulty hearing in background noise and increased tinnitus can lead to significant frustration in social situations and contribute to increased isolation and a decreased quality of life. Treatment options for single sided deafness in the United States include contralateral routing of signals (CROS) hearing aids, bone-anchored hearing aids (BAHA) and use of assistive devices to improve the signal-to-noise in group situations. The first two devices take sound from the affected ear and transmit it to the unaffected ear. The last device consists of having a speaker wear a microphone and routing the signal directly to the patient's ear at a louder listening level. Although these devices can improve speech understanding in some patients, studies have shown that use of these devices does not ameliorate tinnitus or sound localization difficulties. Recent European studies have demonstrated that cochlear implantation (CI) can provide significant improvements in both perceived hearing ability and measured speech comprehension and localization in adult and pediatric patients with unilateral hearing loss. This suggests that CI may be a more effective option for this patient population than the CROS, BAHA or assistive devices.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older with the ability to provide informed consent
  • English as the primary language
  • Medically and psychologically suitable
  • Willing to receive/have received meningitis vaccinations
  • Unsuccessful trial of non-invasive hearing amplification devices or tinnitus treatment as defined by standard of care of six months
  • Able to pay for all care received through the study, either through the subject's insurance company or through self-pay
  • Able to comply with study requirements, including travel to the investigational sites
  • Severe to profound sensorineural hearing loss (≥70 dB thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20% CNC word scores
  • Duration of single-sided deafness ≥ one year
  • Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head

    • Expected subjects include those with:
  • Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis or labyrinthitis
  • Ménière's disease
  • Sudden sensorineural hearing loss
  • Vascular disease affecting the inner ear
  • A combination of any number of the above conditions

Exclusion Criteria:

  • Duration of single-sided deafness ≥ ten years
  • Pure tone thresholds ≥ 35 dB at 500, 1000, 2000, and 4000 Hz in the better ear
  • CNC word scores ≤ 70% in the better ear
  • Chronic otitis media in either ear
  • Inner ear malformation in either ear
  • Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear)
  • Evidence of retrocochlear pathology, including vestibular schwannoma
  • Unilateral tinnitus in the unaffected ear
  • Cochlear ossification
  • Demonstrated cognitive and/or developmental challenges
  • Major depression or anxiety; post-traumatic stress disorder; substance abuse
  • Medical or psychological conditions that serve as contraindication to surgery
  • Additional handicaps that would prevent or limit participation in evaluations
  • Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
  • Pregnant women: The investigators will specifically ask all women of childbearing age if there is a possibility they are pregnant or trying to become pregnant at the initial clinic visit; any women who are pregnant or actively trying to become pregnant will be excluded. In cases that are questionable on the day of planned surgery, a pregnancy test will be performed as per current Massachusetts Eye & Ear Infirmary anesthesia pre-operative protocols.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02532972

Contacts
Contact: Daniel J Lee, MD, FACS 617-573-3130 daniel_lee@meei.harvard.edu
Contact: Barbara S Herrmann, PhD, CCC-A 617-573-3266 barbara_herrmann@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel J Lee, MD, FACS    617-573-3130    daniel_lee@meei.harvard.edu   
Contact: Barbara S Herrmann, PhD, CCC-A    617-573-3266    barbara_herrmann@meei.harvard.edu   
Principal Investigator: Daniel J Lee, MD, FACS         
Sponsors and Collaborators
Dr. Daniel Lee
University of Wisconsin, Madison
Investigators
Principal Investigator: Daniel J Lee, MD, FACS MEEI / MGH
  More Information

Publications:

Responsible Party: Dr. Daniel Lee, Director, Pediatric Otology and Neurotology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02532972     History of Changes
Other Study ID Numbers: 13-054H 
Study First Received: August 14, 2015
Last Updated: January 6, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Unilateral
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on February 11, 2016