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

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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

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE February 3, 2015
Last Update Posted Date April 18, 2016
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Tinnitus Functional Index [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Dietary Supplement: Q10
    Other Name: Ubiquinol
  • Dietary Supplement: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353650
Other Study ID Numbers  ICMJE 14/27/286
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ethisch Comité UZA, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Antwerp
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP