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