TinnitusTICITNCT06085885
Tinnitus and Cochlear Implants
An observational study of Tinnitus, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Dec 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe to profound hearing loss undergoing cochlear implantation.
Who may be able to join
- 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.
Who cannot join
- Significant difficulties preventing independent completion of study activities.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Auditory Implant Programme
Nottingham, Nottinghamshire, NG1 5DU
About this study
Official title: Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation
Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) 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.
Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors after implantation.
Read the detailed description
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:
- Determine the prevalence, nature, and severity of tinnitus before cochlear implantation.
- Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation.
- 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.
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 five follow up assessments after the surgery to receive the cochlear implant, after the first cochlear implant activation appointment, and at routine 1-, 3- and 6-month appointments post-activation. The baseline questionnaires 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). 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).
- Conditions
- Tinnitus
- Being tested
- Cochlear implant
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
Cochlear implant
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant recipients | 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. Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus characteristics and associated medical and sociodemographic factors
The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ). This is a case history questionnaire without a numerical scoring system.
Measured: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Tinnitus impact
Tinnitus Functional Index (TFI). Maximum score: 250, higher score indicates greater tinnitus symptom severity
Measured: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Patient health
Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms
Measured: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Anxiety
Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety
Measured: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Insomnia
Insomnia Severity Index (ISI) scored 0 to 28 with a higher score indicating more severe insomnia
Measured: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Life quality
EuroQol Quality of Life Questionnaire (EQ-5D-5L) scored from 0 to 100, with a lower score indicating worse health
Measured: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Hearing function
Speech, Spatial and Qualities of Hearing (SSQ-12) questionnaire scored 0-120, with a higher score indicating better hearing ability
Measured: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start30 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, Derek Hoare, University of Nottingham
- Investigators
- Derek J Hoare, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085885
- Sponsor's protocol ID
- 23004
- Other IDs
- 292855
- Acronym
- TICIT
- Status last verified
- May 2024
- First submitted
- 11 Aug 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation
- ClinicalTrials.gov ID
- NCT06085885
- Acronym / sponsor ID
- TICIT / 23004
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) 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.
Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors after implantation.
Detailed description
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:
- Determine the prevalence, nature, and severity of tinnitus before cochlear implantation.
- Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation.
- 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.
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 five follow up assessments after the surgery to receive the cochlear implant, after the first cochlear implant activation appointment, and at routine 1-, 3- and 6-month appointments post-activation. The baseline questionnaires 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). 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant recipients | – | Device: Cochlear implantThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe to profound hearing loss undergoing cochlear implantation.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Significant difficulties preventing independent completion of study activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implantCochlear implant | Device | Cochlear implant recipients |
Primary outcome
Tinnitus characteristics and associated medical and sociodemographic factors
Time frame: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ). This is a case history questionnaire without a numerical scoring system.
Tinnitus impact
Time frame: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Tinnitus Functional Index (TFI). Maximum score: 250, higher score indicates greater tinnitus symptom severity
Patient health
Time frame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms
Anxiety
Time frame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety
Insomnia
Time frame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Insomnia Severity Index (ISI) scored 0 to 28 with a higher score indicating more severe insomnia
Life quality
Time frame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
EuroQol Quality of Life Questionnaire (EQ-5D-5L) scored from 0 to 100, with a lower score indicating worse health
Hearing function
Time frame: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Speech, Spatial and Qualities of Hearing (SSQ-12) questionnaire scored 0-120, with a higher score indicating better hearing ability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek J Hoare, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus characteristics and associated medical and sociodemographic factors (time frame: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.