New Therapy for Patients With Severe Tinnitus

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01480193
First received: November 23, 2011
Last updated: November 26, 2013
Last verified: November 2011
  Purpose

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 study is to determine if an integrative medicine approach which targets treatment of the nonauditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms when added to current commonly applied SBE therapies, compared with SBE alone. If successful, this approach will be applied to a larger patient population in future studies to test the generalizability and the durability of the 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.


Condition Intervention
Tinnitus
Other: Sound Based and Educational Therapies
Other: Integrated Medicine Therapies and Sound Based Education Therapies
Other: Integrated Medicine Therapies and SBE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Clinical Trial of an Integrative Therapy With Severe Tinnitus

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory [ Time Frame: baseline, post treatment, and 3month follow-up ] [ Designated as safety issue: No ]
    Primary outcome measure is score on the THI, with a 20-point or greater decrease from baseline representing a clinically significant improvement to be tested for statistical significance at the 5 percent confidence level.


Enrollment: 40
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Integrated Medicine Therapies and Sound Based Education Therapies
3 Cognitive Based Therapy Sessions, 9 Telephonic Health Coaching Sessions 5 Acupuncture Sessions Group-Based 8 week Mindfulness Based Stress Reduction
Experimental: Integrated 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: Integrated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480193

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Debara Tucci, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01480193     History of Changes
Other Study ID Numbers: Pro00030594, 1R21DC011643-01
Study First Received: November 23, 2011
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Tinnitus

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014