New Therapy for Patients With Severe Tinnitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01480193 |
Recruitment Status :
Completed
First Posted : November 28, 2011
Last Update Posted : April 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Tinnitus | Other: Sound Based and Educational Therapies Other: Integrative Medicine Therapies and Sound Based Education Therapies | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This pilot trial will employ a randomized controlled design in a 3:1 allocation series to gain experience with the experimental intervention. |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | Data management and analysis will be provided by blinded personnel. |
Primary Purpose: | Other |
Official Title: | Preliminary Clinical Trial of an Integrative Therapy With Severe Tinnitus |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |
Arm | Intervention/treatment |
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Active Comparator: Sound Based and Educational Therapies
The SBE program will consist of two hour-long individual counseling and sound therapy sessions based on the Department of Veterans Affairs Progressive Audiologic Tinnitus Management approach. SBE treatment incorporates the use of education, counseling, increased relaxation and decreased stress, along with the integration of sound therapy to better manage the impact of tinnitus.
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Other: Sound Based and Educational Therapies
The SBE program will consist of two hour-long individual counseling and sound therapy sessions based on the Department of Veterans Affairs Progressive Audiologic Tinnitus Management approach. SBE treatment incorporates the use of education, counseling, increased relaxation and decreased stress, along with the integration of sound therapy to better manage the impact of tinnitus. |
Experimental: Integrative Medicine Therapies and SBE
2 Sound Based and Educational Sessions 3 Cognitive Based Therapy Sessions 9 Telephonic Health Coaching Sessions 5 Acupuncture Sessions Group-Based 8 week Mindfulness Based Stress Reduction
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Other: Sound Based and Educational Therapies
The SBE program will consist of two hour-long individual counseling and sound therapy sessions based on the Department of Veterans Affairs Progressive Audiologic Tinnitus Management approach. SBE treatment incorporates the use of education, counseling, increased relaxation and decreased stress, along with the integration of sound therapy to better manage the impact of tinnitus. Other: Integrative Medicine Therapies and Sound Based Education Therapies 3 Cognitive Based Therapy Sessions, 9 Telephonic Health Coaching Sessions, 5 Acupuncture Sessions, and Group-Based 8 week Mindfulness Based Stress Reduction Provided synergistically through an integrative medicine paradigm |
- Feasibility of implementing the integrative medicine intervention in an RCT [ Time Frame: baseline, 6 months post-baseline ]enrollment, retention, and patient feedback
- patient satisfaction [ Time Frame: 6 months post-baseline ]Likert scales assessing patient perceptions of the integrative intervention
- Tinnitus-related dysfunction [ Time Frame: baseline, 6 months post-baseline, 9 mos post baseline ]Tinnitus Handicap Questionnaire (THI) is a patient-reported survey that indicates dysfunction from tinnitus

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Debilitating tinnitus, defined by score on the Tinnitus Hearing Inventory > 38;
- Participation not ruled out by baseline medical exam (see below);
- Age 18 or older (no upper age limit);
- No acute systemic illness requiring frequent treatment such as chemotherapy, dialysis, and no such treatment in the past 3 months,
- Able to speak, read and write in English,
- Willingness to participate fully in either treatment arm when randomized,
- Not currently enrolled in another clinical trial or taking an experimental
- No previous experience with either Sound Based and Educational (SBE) therapies as applied in this study or an Integrated Medicine approach specifically for the treatment of tinnitus symptoms; and
- Adequate hearing to allow participation in the SBE treatment program.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480193
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Debara Tucci, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01480193 |
Other Study ID Numbers: |
Pro00030594 1R21DC011643-01 ( U.S. NIH Grant/Contract ) |
First Posted: | November 28, 2011 Key Record Dates |
Last Update Posted: | April 9, 2019 |
Last Verified: | January 2019 |
Tinnitus |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |