Tinnitus Clinical Trial
Official title:
Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation
Primary objective: Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss. Secondary objectives: 1. Determine the prevalence, nature, and severity of tinnitus before cochlear implantation. 2. Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation. 3. Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus. Patient identification: Providers of cochlear implantation services on the National Health Service in the United Kingdom. Standard questionnaires: Completed remotely by participants using a computer or other preferred electronic device. The sample will comprise adults determined as eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Inclusion criteria - 18 years or older. - Determined to be eligible for unilateral cochlear implantation. - Did not previously receive a cochlear implant in either ear. - Sufficient written or spoken English to participate in study activities. - Have access to internet or suitable device to complete online study questionnaires. - Able to give informed consent. Exclusion criteria - Significant difficulties preventing independent completion of study activities. This study involves no clinical interventions beyond cochlear implantation that will be already available to participants as part of their routine care pathway. Participants will undergo routine pre- and post-operative assessments as part of usual care. Online questionnaires will include standard instruments used to assess: - Tinnitus and its characteristics, related socio-demographic, lifestyle and health-related factors, and access to tinnitus care as measured with the European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ) - Tinnitus impact as measured with the Tinnitus Functional Index (TFI) - Tinnitus-related psychological symptoms including anxiety as measured with the Patient Health Questionnaire (PHQ-9) mood as measured with the Generalised Anxiety Disorder Assessment (GAD-7) and insomnia as measured using the Insomnia Severity Index (ISI) - Quality of life sensitive to changes in hearing as measured with the Health Utilities Index (HUI-3), and health and tinnitus as measured with the EuroQol Quality of Life Questionnaire (EQ-5D-5L) - Hearing function (SSQ-12) The schedule of questionnaires will follow the schedule of routine clinical appointments as part of the cochlear implantation care pathway including a pre-operative baseline assessment, and 5 follow up assessments after the surgery to receive the cochlear implant, after first cochlear implant activation appointment, and at routine 1-, 3- and 6-month appointments post-activation. The baseline questionnaire will require about 40 min to complete and follow up questionnaires about 15-30 min. Detailed analyses will be specified prospectively in a study analysis plan developed by the study team. Data analyses will be conducted by the study team with support from medical statisticians at the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC) and/or the University of Nottingham. The software utilised for analyses may include Excel, SPSS, R or MATLAB. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors before and after implantation. Data analyses will include descriptive statistics, General/Generalised Linear Models (e.g., ANOVA, regression models) or non-parametric statistical methods where appropriate (e.g., Mann Whitney U test).
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Recruiting |
NCT04987502 -
Virtual Reality and Subjective Tinnitus
|
N/A | |
Recruiting |
NCT04404439 -
Treatment of Tinnitus With Migraine Medications
|
Phase 4 | |
Recruiting |
NCT05533840 -
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
|
||
Completed |
NCT03552302 -
Effects of Yoga Exercise on Participates With Tinnitus
|
||
Enrolling by invitation |
NCT02617953 -
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus
|
N/A | |
Completed |
NCT02974543 -
Somatosensory Stimulation to Alleviate Tinnitus
|
N/A | |
Withdrawn |
NCT01663467 -
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy
|
N/A | |
Completed |
NCT02269839 -
A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
|
N/A | |
Completed |
NCT01929837 -
Tinnitus rTMS 2013
|
N/A | |
Completed |
NCT01857661 -
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
|
N/A | |
Completed |
NCT01927991 -
Internet-based Self-help for Tinnitus: The Role of Support
|
N/A | |
Terminated |
NCT01412918 -
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
|
N/A | |
Completed |
NCT01480193 -
New Therapy for Patients With Severe Tinnitus
|
N/A | |
Completed |
NCT00371436 -
Progressive Intervention Program for Tinnitus Management
|
N/A | |
Completed |
NCT00748475 -
Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus
|
N/A | |
Completed |
NCT00733044 -
Cost-effectiveness of Multidisciplinary Management of Tinnitus
|
N/A | |
Active, not recruiting |
NCT05518682 -
Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus
|
N/A | |
Recruiting |
NCT05212298 -
Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus
|
N/A | |
Completed |
NCT06025097 -
Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.
|
Early Phase 1 |