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

April 14, 2016 updated by: Ethisch Comité UZA, University Hospital, Antwerp
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • University Hospital of Antwerp
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tinnitus Functional Index
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Audiometric tresholds test
Time Frame: 2 months
2 months
Tinnitus Analysis _ loudness matches
Time Frame: 2 months
2 months
Tinnitus Analysis_Minimal masking level
Time Frame: 2 months
2 months
Visual Analogue Scale of loudness
Time Frame: 2 months
2 months
Hospital Anxiety and Depression Scale
Time Frame: 2 months
2 months
Hyperacusis Questionnaire
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/27/286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe