New Therapy for Patients With Severe Tinnitus

NCT ID: NCT01480193

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-11-30

Brief Summary

Tinnitus is a common problem for which there is no universally effective treatment. The best available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over $345.5 million. Individuals with persistent severe tinnitus are unable to habituate to the tinnitus sound that most likely originates in the central auditory system (CAS) in response to peripheral injury. In a widely referenced study, it has been hypothesized that lack of habituation is secondary to abnormal processing of sensory information. Specifically, processing by the limbic system and autonomic nervous system is apparently abnormal in patients with increased levels of cortical arousal and inadequate coping mechanisms. In otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment, additional treatment options are necessary particularly for those with significant non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who do not experience significant improvement with SBE. Furthermore, commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year to become effective and may not be used in patients with hearing that is too poor to be modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment and the known percentage who do not respond to commonly used therapies, we estimate that 1.2 million individuals are not able to benefit at all from current, widely used treatment strategies. A new strategy to augment those currently used could empower patients to exert control over their tinnitus symptoms without the use of medications, expensive devices such as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be useful both for patients who are not candidates for SBE and for those who respond poorly. An Integrative Medicine approach provides a likely solution. To date, there has been no systematic study of the benefits of an Integrative Medicine approach for severe tinnitus, particularly for non-auditory aspects of tinnitus symptoms. The goal of the proposed pilot study is to assess the feasibility of studying an integrative medicine approach in a subsequent large clinical trial which targets treatment of the non-auditory aspects of tinnitus suffering. Specifically, we wish to gain experience using the intervention in a randomized clinical trial when adding it to current commonly applied SBE therapies, compared with SBE alone. We also plan to assess patient satisfaction with the intervention, and obtain preliminary clinical efficacy data. If evaluating this intervention in an RCT appears feasible, this approach will be applied to a larger trial patient population in future studies to hypothesis test its efficacy and the durability of the potential effect. Our eventual goal is to develop a streamlined approach that individualizes tinnitus treatment based on symptoms and patient characteristics, and that can be widely applied in general medical practice.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sound Based and Educational Therapies

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Sound Based and Educational Therapies

Intervention Type: OTHER

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.

Integrative Medicine Therapies and Sound Based Education Therapies

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Debilitating tinnitus, defined by score on the Tinnitus Hearing Inventory > 38;

2. Participation not ruled out by baseline medical exam (see below);

3. Age 18 or older (no upper age limit);

4. No acute systemic illness requiring frequent treatment such as chemotherapy, dialysis, and no such treatment in the past 3 months,

5. Able to speak, read and write in English,

6. Willingness to participate fully in either treatment arm when randomized,

7. Not currently enrolled in another clinical trial or taking an experimental

8. 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

9. Adequate hearing to allow participation in the SBE treatment program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debara Tucci, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1R21DC011643-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00030594

Identifier Type: -

Identifier Source: org_study_id