NCT00748475

Brief Summary

The purpose of the study is to examine the effect of alpha-neurofeedback while subjects listen to a noise on tinnitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

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

September 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

September 5, 2008

Last Update Submit

February 19, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reduction of tinnitus distress using the Tinnitus Questionaire

    Before the first and after the last session.

  • Cortical Alpha Power

    Before the first and after the last session

Study Arms (1)

Neurofeedback

EXPERIMENTAL
Behavioral: Neurofeedback

Interventions

NeurofeedbackBEHAVIORAL
Neurofeedback

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Duration of Tinnitus \>= 6 months and \<= 20 years
  • Subjective Tinnitus

You may not qualify if:

  • History of neurological or more than mild psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Nathan Weisz, PhD

    University Konstanz

    PRINCIPAL INVESTIGATOR
  • Thomas Hartmann, Dipl.-Psych.

    University Konstanz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Nathan Weisz

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Last Updated

February 20, 2013

Record last verified: 2013-02