NCT02353650

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

January 22, 2015

Last Update Submit

April 14, 2016

Conditions

Tinnitus

Keywords

Q10ubiquinol

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Functional Index

    2 months

Secondary Outcomes (6)

  • Audiometric tresholds test

    2 months

  • Tinnitus Analysis _ loudness matches

    2 months

  • Tinnitus Analysis_Minimal masking level

    2 months

  • Visual Analogue Scale of loudness

    2 months

  • Hospital Anxiety and Depression Scale

    2 months

  • +1 more secondary outcomes

Interventions

Q10DIETARY_SUPPLEMENT
Also known as: Ubiquinol
placeboDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic non-pulsatile tinnitus \> 3 months
  • tinnitus has a clear otological cause
  • age \> 18 years

You may not qualify if:

  • pulsatile tinnitus
  • persons who take already Q10
  • pregnancy
  • cervical tinnitus
  • holocranial tinnitus
  • depression
  • mental of neurological disorders
  • history of chemotherapy
  • middle ear diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Tuberculinubiquinol

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethics Committee

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 3, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

BE(1)