Phase Out in Tinnitus Patients

Tinnitus Clinical Trial

Official title:

Phase Out Treatment for Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833950
• Other study ID #: 8/2/12
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2009
• Last updated: March 2, 2009
• Start date: March 2008

Study information

• Verified date: December 2008
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Phase Out treatment in pure tone tinnitus patients
Phase Out treatment: 30 min 3x/w during 6 weeks

Locations

Country	Name	City	State
Belgium	Antwerp university Hospital	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	Visual Analogue Scale		3x/week	No
Secondary	Score on Tinnitus Questionnaire		week 0, week 3, week 6	No