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

Tinnitus Clinical Trial

— CALM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00730834
• Other study ID #: CALM Study
• Secondary ID: 20071022
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: August 24, 2009
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2009
• Source: Neuromonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperacusis
• Tinnitus

Intervention

Device:
• Oasis
Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds

Locations

Country	Name	City	State
United States	Silverstein Ear Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neuromonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and post treatment scores on Tinnitus reaction questionnaire		6, 12, 24, 36 months	No
Secondary	Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,		6, 12, 24, 36 months	No

External Links

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