Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis - Full Text View

Sponsored by:	Neuromonics, Inc.
Information provided by:	Neuromonics, Inc.
ClinicalTrials.gov Identifier:	NCT00730834

Purpose

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).

Condition	Intervention	Phase
Tinnitus Hyperacusis	Device: Oasis	Phase IV

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Pahse 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Further study details as provided by Neuromonics, Inc.:

Primary Outcome Measures:

Pre and post treatment scores on Tinnitus reaction questionnaire [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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, socre on HADS of greater than 11 on the anxiety and depression scale,
Not willing to follow the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730834

Contacts

Contact: Julie Daugherty, RN

941-366-9222

Locations

United States, Florida
Silverstein Ear Institute	Recruiting
Sarasota, Florida, United States, 34239
Contact: Julie 941-366-9222
Sub-Investigator: Julie Daugherty, RN
Principal Investigator: Jack Wazen, MD

Sponsors and Collaborators

Neuromonics, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Silverstein ear institute ( Jack Wazen, MD )
Study ID Numbers:	CALM Study, 20071022
Study First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730834
Health Authority:	United States: Institutional Review Board

Keywords provided by Neuromonics, Inc.:

tinnitus
ringing in the ears
buzzing
static
hyperacusis

loudness discomfort
Clinically
significant
discomfort

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Hyperacusis
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009