The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients

NCT ID: NCT02353650

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Q10

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ubiquinol

Eligibility Criteria

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Inclusion Criteria

* chronic non-pulsatile tinnitus \> 3 months
* tinnitus has a clear otological cause
* age \> 18 years

Exclusion Criteria

* pulsatile tinnitus
* persons who take already Q10
* pregnancy
* cervical tinnitus
* holocranial tinnitus
* depression
* mental of neurological disorders
* history of chemotherapy
* middle ear diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZA

Ethics Committee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Antwerp

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Sarah Rabau

Role: primary

003238215235

Other Identifiers

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14/27/286

Identifier Type: -

Identifier Source: org_study_id

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