Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

Phase 4

• Conditions: Tinnitus; Hyperacusis

• Registration Number: NCT00730834
• Lead Sponsor: Neuromonics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pre and post treatment scores on Tinnitus reaction questionnaire	6, 12, 24, 36 months

Secondary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,	6, 12, 24, 36 months

Trial Locations

Locations (1)

Silverstein Ear Institute; 🇺🇸 Sarasota, Florida, United States