NCT00833950

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

March 3, 2009

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

January 30, 2009

Last Update Submit

March 2, 2009

Conditions

Tinnitus

Keywords

TinnitusPhase Out

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    3x/week

Secondary Outcomes (1)

  • Score on Tinnitus Questionnaire

    week 0, week 3, week 6

Study Arms (1)

narrow band noise

EXPERIMENTAL

Phase out in narrow band noise tinnitus patients

Device: Phase Out treatment in pure tone tinnitus patients

Interventions

Phase Out treatment in pure tone tinnitus patientsDEVICE

Phase Out treatment: 30 min 3x/w during 6 weeks

narrow band noise

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • depression: BDI \> 21
  • pulsatile tinnitus
  • pregnancy
  • epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp university Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 2, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Last Updated

March 3, 2009

Record last verified: 2008-12

Locations

BE(1)