Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
ConditionHearing Loss, Sensorineural
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorTodoc
About this trial
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older
No previous cochlear implantation history in the ear scheduled for surgery
No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests
Patients without cancer, autoimmune disease, or neurological disease
Disqualifiers
Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.
Cases with cancer or autoimmune disease
Cases with a general condition that makes it difficult to tolerate general anesthesia
Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education
Trial design
Design model
Single group
Treatments tested in this trial
Sullivan
DevicePatients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments. Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: SullivanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in open-set sentence recognition
Sentences will be presented before the implant surgery, and at 12- and 24-weeks post implant, to assess and record the patient's sentence recognition ability. A total of 10 sentences, comprising 50 words, will be used for this evaluation. For each sentence, the percentage of correctly recognized words will be calculated out of the total 50 words across the 10 sentences. Sentence recognition abilities for each participant will be assessed at pre-surgery, 12 weeks, and 24 weeks. Improvement in sentence recognition at 12 weeks and 24 weeks will be determined by comparing these post-implant scores with pre-surgery scores.
Time frame
at 12-week and 24-week post-implantSecondary outcomes
1
Change in open-set monosyllabic word recognition
Pre- and post-implant (at 12 and 24 weeks) monosyllabic word recognition will be assessed by presenting words auditorily, with results recorded, compared, and observed. The assessment will use 20 monosyllabic words. For each participant, pre-surgery, 12-week, and 24-week monosyllabic word recognition scores will be calculated as the percentage of correctly recognized words out of the total 20 words. The difference in monosyllabic word recognition between pre-surgery and 12 weeks post-surgery, as well as between pre-surgery and 24 weeks post-surgery, will be calculated.
Time frame
at the 12-week and 24-week post-implant2
Change in open-set bisyllabic word recognition
Pre- and post-implant (at 12 and 24 weeks) bisyllabic word recognition will be assessed by presenting words auditorily, with results recorded, compared, and observed. The cognitive assessment will use 20 bisyllabic words. For each participant, pre-surgery, 12-week, and 24-week bisyllabic word recognition scores will be calculated as the percentage of correctly recognized words out of the total 20 words. The difference in bisyllabic word recognition between pre-surgery and 12 weeks post-surgery, as well as between pre-surgery and 24 weeks post-surgery, will be calculated.
Time frame
at the 12-week and 24-week post-implant3
Change in pure-tone hearing thresholds
The average minimum pure-tone hearing thresholds before and after implant surgery (at 12 and 24 weeks) will be compared and observed. The average minimum pure-tone hearing threshold is calculated as the mean of the minimum hearing thresholds at 500, 1000, 2000, and 3000 Hz.
Time frame
at the 12-week and 24-week post implantLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Todoc
Lead sponsor
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: