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

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Q10
placebo
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Q10, ubiquinol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital of AntwerpRecruiting

Outcomes

Primary Outcome Measures

Tinnitus Functional Index

Secondary Outcome Measures

Audiometric tresholds test
Tinnitus Analysis _ loudness matches
Tinnitus Analysis_Minimal masking level
Visual Analogue Scale of loudness
Hospital Anxiety and Depression Scale
Hyperacusis Questionnaire

Full Information

First Posted
January 22, 2015
Last Updated
April 14, 2016
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT02353650
Brief Title
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Q10, ubiquinol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Q10
Other Intervention Name(s)
Ubiquinol
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Tinnitus Functional Index
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Audiometric tresholds test
Time Frame
2 months
Title
Tinnitus Analysis _ loudness matches
Time Frame
2 months
Title
Tinnitus Analysis_Minimal masking level
Time Frame
2 months
Title
Visual Analogue Scale of loudness
Time Frame
2 months
Title
Hospital Anxiety and Depression Scale
Time Frame
2 months
Title
Hyperacusis Questionnaire
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University hospital of Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Rabau
Phone
003238215235
Email
sarah.rabau@uza.be

12. IPD Sharing Statement

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

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