New Therapy for Patients With Severe Tinnitus

Preliminary Clinical Trial of an Integrative Therapy With Severe Tinnitus

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Other: Sound Based and Educational Therapies; Other: Integrative Medicine Therapies and Sound Based Education Therapies

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing the integrative medicine intervention in an RCT	enrollment, retention, and patient feedback	baseline, 6 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	Likert scales assessing patient perceptions of the integrative intervention	6 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus-related dysfunction	Tinnitus Handicap Questionnaire (THI) is a patient-reported survey that indicates dysfunction from tinnitus	baseline, 6 months post-baseline, 9 mos post baseline

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Debara Tucci, MD, Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: November 25, 2011
• First Posted (Estimate): November 28, 2011

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Tinnitus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: Pro00030594; 1R21DC011643-01 (U.S. NIH Grant/Contract)