TinnitusNCT02353650
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
A study testing Q10 in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- chronic non-pulsatile tinnitus > 3 months
- tinnitus has a clear otological cause
- age > 18 years
Who cannot join
- pulsatile tinnitus
- persons who take already Q10
- pregnancy
- cervical tinnitus
- holocranial tinnitus
- depression
Show all 9Show fewer
- mental of neurological disorders
- history of chemotherapy
- middle ear diseases
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University hospital of Antwerp
Edegem, Antwerp, 2650
Sarah Rabau, 003238215235, sarah.rabau@uza.be
About this study
The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.
- Conditions
- Tinnitus
- Being tested
- Q10, placebo
- Keywords
- Q10, ubiquinol
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q10Dietary supplement
Also called Ubiquinol
placeboDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index
Measured: 2 months
Secondary outcomes (6)
Audiometric tresholds test
Measured: 2 months
Tinnitus Analysis _ loudness matches
Measured: 2 months
Tinnitus Analysis_Minimal masking level
Measured: 2 months
Visual Analogue Scale of loudness
Measured: 2 months
Hospital Anxiety and Depression Scale
Measured: 2 months
Hyperacusis Questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2016 (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.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353650
- Sponsor's protocol ID
- 14/27/286
- Status last verified
- Apr 2016
- First submitted
- 22 Jan 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
- ClinicalTrials.gov ID
- NCT02353650
- Acronym / sponsor ID
- 14/27/286
- Conditions
- Tinnitus
- Keywords
- Q10, ubiquinol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 3 Feb 2015 (estimated)
- 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.
The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic non-pulsatile tinnitus > 3 months
- tinnitus has a clear otological cause
- age > 18 years
Key exclusion criteria (9 listed)
- pulsatile tinnitus
- persons who take already Q10
- pregnancy
- cervical tinnitus
- holocranial tinnitus
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 |
|---|---|---|
| Q10Also: Ubiquinol | Dietary supplement | – |
| placebo | Dietary supplement | – |
Primary outcome
Tinnitus Functional Index
Time frame: 2 months
6 secondary outcomes
Audiometric tresholds test
Time frame: 2 months
Tinnitus Analysis _ loudness matches
Time frame: 2 months
Tinnitus Analysis_Minimal masking level
Time frame: 2 months
Visual Analogue Scale of loudness
Time frame: 2 months
Hospital Anxiety and Depression Scale
Time frame: 2 months
Hyperacusis Questionnaire
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q10 in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 inclusion and 9 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 18 Apr 2016. 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (time frame: 2 months). 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 18 Apr 2016.