CI Following VS Removal or Labyrinthectomy
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|ClinicalTrials.gov Identifier: NCT03795675|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma Meniere Disease||Device: Cochlear Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2025|
Experimental: Meniere's Disease/Vestibular Schwannoma
Individuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery.
Device: Cochlear Implant
Cochlear implant device to be implanted at time of surgical intervention.
- Change in Sound Detection Testing [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Sounds that vary in pitch (frequency) will be presented in a sound field to identify hearing thresholds in decibels (dB). Participant indicates when a sound is detected/perceived when listening with the cochlear implant. The softest sound at each specific frequency (125, 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hertz (Hz)) will be recorded in dB hearing level.
- Change in Speech Perception Testing [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Arizona (AZ) Bio sentences (speech perception test comprised of 660 unique sentences, presented in 33 independent lists of 20 sentences each) and the Maryland consonant-vowel nucleus-consonant (CNC) (10 phonetically balanced 50-word lists) word lists will be presented through a sound field speaker, and participant will be asked to repeat back the sentences and/or word that was heard. Background noise will be presented in conjunction with the sentences/words at various signals to noise levels (quiet [no noise], +0 dB and +5 dB signal to noise ratio). The percentage of sentences/words correctly repeated will be calculated for each test (AZ Bio, CNC) at each signal to noise level. Higher percentages indicate better word and sentence recognition ability.
- Change in Sound Localization Testing [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Participant listens to bursts of sounds (100 trials of pink noise [random noise having equal energy per octave and having more low-frequency components than white noise; the power per hertz decreases as the frequency increases] presented randomly from seven speakers in a half-moon orientation and identifies which speaker presented the sounds. Two testing conditions will be evaluated (implant on, implant off). Total percentage of sounds correctly identified for each condition (0-100%) will be calculated, with a larger percentage indicating higher accuracy. Additionally, root mean square error (average of total degree of error when localizing) will be calculated for each trial.
- Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Subjective questionnaire designed to study the relationship of disability and handicap across many listening domains using 49 questions in a clinician/patient interview format. The scale is sub-divided into three domains: 14 items on speech hearing, 17 items on spatial hearing (direction and distance judgments), and 18 items on "other" functions and qualities of hearing. The "other" qualities section contains items related to recognition and segregation of sounds, clarity, naturalness, and listening effort. Items are scored with ratings of 0 to 10, with 0 representing complete inability with regard to the item in question and 10 representing perfect ability. The average score (0-10) for each subscale/domain is reported individually.
- Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Questionnaire encompassing hearing and speech, psychological, and social domains and is used to evaluate quality of life. This questionnaire contains six subdomains of hearing that are rated categorically (1-5 (never-always) and "not applicable"). The subdomains are 1. Basic sound perception, 2. Advanced sound perception (in difficult daily listening situations or background noise), 3. Speech production, 4. Self-esteem, 5. Activity limitations, 6. Social interaction. The answer categories must first be transformed (1=0, 2=25, 3=50, 4=75 and 5=100). Afterwards, the final subdomain score is computed by adding together all the item scores and dividing by the number of completed items, resulting in a range of scores from 0 to 100. A higher score reflects a greater ability.
- Change in Tinnitus Handicap Inventory (THI) Scores [ Time Frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation. ]Subjective questionnaire that identifies, qualifies, and evaluates the difficulties that may be experienced due to tinnitus. It is a 25-item questionnaire grouped into three subscales: functional, emotional and catastrophic responses. The functional subscale items reflect the effect of tinnitus on mental, social, occupational and physical functioning. The emotional subscale items probe the individual's emotional reactions to tinnitus, and the catastrophic response items address whether tinnitus makes the respondent feel desperate, trapped, hopeless or out of control. A "yes" response is given 4 points, a "sometimes" response 2 points and a "no" response 0 points. The questionnaire yields scores for each subscale and a total score that ranges from 0 and 100, with high scores indicating a greater handicap. The total score of this questionnaire represents the overall severity of tinnitus: slight (0-16), mild (18-36), moderate (38-56), severe (58-76) or catastrophic (78-100).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795675
|Contact: Meghan Hiss, AuD||614-366-1549||Meghan.Hiss@osumc.edu|
|Contact: William Riggs, AuD||614-293-9750||William.Riggs@osumc.edu|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Oliver Adunka, MD||Ohio State University|