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Clinical Trials/NCT00730834
NCT00730834
Unknown
Phase 4

Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Neuromonics, Inc.1 site in 1 country53 target enrollmentJune 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Tinnitus
Sponsor
Neuromonics, Inc.
Enrollment
53
Locations
1
Primary Endpoint
Pre and post treatment scores on Tinnitus reaction questionnaire
Last Updated
16 years ago

Overview

Brief Summary

Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
December 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 18 years of age,
  • TRQ of at least 17 or above,
  • Able to pay for the treatment,
  • Not using any other treatment for tinnitus,
  • Access to computer and internet,
  • Compliant patient

Exclusion Criteria

  • Hearing PTA \> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
  • Not willing to follow the protocol

Outcomes

Primary Outcomes

Pre and post treatment scores on Tinnitus reaction questionnaire

Time Frame: 6, 12, 24, 36 months

Secondary Outcomes

  • Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,(6, 12, 24, 36 months)

Study Sites (1)

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