Overview

This trial is active, not recruiting.

Conditions tinnitus, hyperacusis
Treatment oasis
Phase phase 4
Sponsor Neuromonics, Inc.
Start date June 2007
End date December 2010
Trial size 53 participants
Trial identifier NCT00730834, 20071022, CALM Study

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Pre and post treatment scores on Tinnitus reaction questionnaire
time frame: 6, 12, 24, 36 months

Secondary Outcomes

Measure
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,
time frame: 6, 12, 24, 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Neuromonics, Inc..