The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients: a Double-blinded Randomized Trial.

Tinnitus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02353650
• Other study ID #: 14/27/286
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2015
• Last updated: February 2, 2015
• Start date: November 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee Antwerp
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Dietary Supplement:
• Q10

• placebo

Locations

Country	Name	City	State
Belgium	University hospital of Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Functional Index		2 months
Secondary	Audiometric tresholds test		2 months
Secondary	Tinnitus Analysis _ loudness matches		2 months
Secondary	Tinnitus Analysis_Minimal masking level		2 months
Secondary	Visual Analogue Scale of loudness		2 months
Secondary	Hospital Anxiety and Depression Scale		2 months
Secondary	Hyperacusis Questionnaire		2 months