CINGLE-studie: Cochleaire Implantatie bij siNGLE-sided deafness

CINGLE-trial: Cochlear Implantation for siNGLE-sided deafness



Rationale: Patients who develop single-sided deafness (SSD) become aware of the importance of hearing with two ears in everyday listening environments. Current clinical practice for patients with SSD consists of optimizing hearing using a Bone Conduction Device (BCD) or a Contralateral Routing of Sound system (CROS). With both devices sound awareness on the deaf side can be improved, but they do not provide bilateral auditory input, which is needed to achieve the actual benefits of hearing with two ears. These limitations may be overcome by providing a cochlear implant (CI) and consequently generating auditory input to the affected ear.



Objective: The objectives of this study are to evaluate the clinical outcomes gained from having a cochlear implant (CI) over standard health care therapy with either BCD or CROS in patients with SSD and to examine the cost utility of cochlear implantation in these patients.



Study design: 120 subjects with acute (≥3 months and ≤10 years onset) SSD will be included in this Randomised Controlled Trial (RCT) after their informed consent. 30 Subjects shall receive a CI on the deaf side after randomisation (Group A). The other 90 subjects shall start with a 6-week during test period with either a BCD on a headband (n = 45, Group B) or with a CROS (n = 45, Group C). After these 6 weeks, patients in group B switch to a test period with a CROS for 6 weeks and vice versa for patients in group C. After completing both test periods patients in group B and group C will choose for further treatment with a CROS, a definitive surgically implanted BCD or no treatment. The follow-up sessions will take place 3, 6, 12, 18, 24, 36, 48 and 60 months after randomisation for participants in all groups.



Study population: 120 subjects aged 18 or older with postlingual SSD who are eligible for cochlear implantation.



Intervention (if applicable): Cochlear Implantation versus BCD or CROS



Main study parameters/endpoints: The main outcome will be the performance on the modified Plomp hearing test. Secondary outcome measures will be: performance on the Standard Dutch phoneme test (NvA-list), the Speech intelligibility test with spatially separated sources, the Crescent of sound test (Quentin Summerfield), self-reported benefits in everyday listening situations and quality of life assessed with the Speech, Spatial and Qualities Hearing Scale (SSQ), Abbreviated Profile of Hearing Aid Benefit (APHAB), Health Utilities Index (HUI3), Glasgow Benefit Inventory (GBI), Hospital Anxiety and Depression Score (HADS), Time Trade-Off (TTO), Visual Analogue Scales (VAS) and EuroQol-5D (EQ5D) and tinnitus questionnaires (Tinnitus Handicap Inventory [THI], Tinnitus Questionnaire [TQ] and Tinnitus Burden Questionnaire). Participants will keep a monthly diary to assess cost utility.

Patients who develop single-sided deafness (SSD) become aware of the importance of hearing with two ears in everyday listening environments. Current clinical practice for patients with SSD consists of optimizing hearing using a Bone Conduction Device (BCD) or a Contralateral Routing of Sound system (CROS). With both devices sound awareness on the deaf side can be improved, but they do not provide bilateral auditory input, which is needed to achieve the actual benefits of hearing with two ears. These limitations may be overcome by providing a cochlear implant (CI) and consequently generating auditory input to the affected ear.

Baseline and 3, 6, 12, 18, 24, 36, 48 and 60 months post-activation

Randomised:

Cochlear Implantation (CI) versus Bone Conduction Device (BCD) or Contralateral Routing of Sound system (CROS)