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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353650
Recruitment Status : Unknown
Verified April 2016 by Ethisch Comité UZA, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : February 3, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZA, University Hospital, Antwerp

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Tinnitus Dietary Supplement: Q10 Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus


Intervention Details:
  • Dietary Supplement: Q10
    Other Name: Ubiquinol
  • Dietary Supplement: placebo


Primary Outcome Measures :
  1. Tinnitus Functional Index [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Audiometric tresholds test [ Time Frame: 2 months ]
  2. Tinnitus Analysis _ loudness matches [ Time Frame: 2 months ]
  3. Tinnitus Analysis_Minimal masking level [ Time Frame: 2 months ]
  4. Visual Analogue Scale of loudness [ Time Frame: 2 months ]
  5. Hospital Anxiety and Depression Scale [ Time Frame: 2 months ]
  6. Hyperacusis Questionnaire [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353650


Locations
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Belgium
University hospital of Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Sarah Rabau    003238215235    sarah.rabau@uza.be   
Sponsors and Collaborators
University Hospital, Antwerp
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Responsible Party: Ethisch Comité UZA, Ethics Committee, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02353650    
Other Study ID Numbers: 14/27/286
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Keywords provided by Ethisch Comité UZA, University Hospital, Antwerp:
Q10
ubiquinol
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms