Back to resultsPhase Out in Tinnitus Patients
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Phase Out treatment in pure tone tinnitus patients
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Phase Out
Eligibility Criteria
Inclusion Criteria:
- consult ENT department UZA with tinnitus
- pure tone tinnitus or narrow band noise tinnitus
- unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
- frequency tinnitus > 1kHz
- cochlear origin tinnitus
- tinnitus duration 3 months or longer
- age 18y or more
- patient being able to cooperate
- patiënt able to fill in VAS
- normal MRI pontine angle
Exclusion Criteria:
- depression: BDI > 21
- pulsatile tinnitus
- pregnancy
- epilepsy
Sites / Locations
- Antwerp university Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
narrow band noise
Arm Description
Phase out in narrow band noise tinnitus patients
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Secondary Outcome Measures
Score on Tinnitus Questionnaire
Full Information
NCT ID
NCT00833950
First Posted
January 30, 2009
Last Updated
March 2, 2009
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00833950
Brief Title
Phase Out in Tinnitus Patients
Official Title
Phase Out Treatment for Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.
The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Phase Out
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
narrow band noise
Arm Type
Experimental
Arm Description
Phase out in narrow band noise tinnitus patients
Intervention Type
Device
Intervention Name(s)
Phase Out treatment in pure tone tinnitus patients
Intervention Description
Phase Out treatment: 30 min 3x/w during 6 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
3x/week
Secondary Outcome Measure Information:
Title
Score on Tinnitus Questionnaire
Time Frame
week 0, week 3, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consult ENT department UZA with tinnitus
pure tone tinnitus or narrow band noise tinnitus
unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
frequency tinnitus > 1kHz
cochlear origin tinnitus
tinnitus duration 3 months or longer
age 18y or more
patient being able to cooperate
patiënt able to fill in VAS
normal MRI pontine angle
Exclusion Criteria:
depression: BDI > 21
pulsatile tinnitus
pregnancy
epilepsy
Facility Information:
Facility Name
Antwerp university Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Phase Out in Tinnitus Patients
We'll reach out to this number within 24 hrs