Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01480193
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2011-11-23
Brief Title:
New Therapy for Patients With Severe Tinnitus
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Preliminary Clinical Trial of an Integrative Therapy With Severe Tinnitus
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US Department of Veterans Affairs VA the economic impact of tinnitus is thought to be substantial The VA reported in 2004 that 289159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over 3455 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 eg 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 egTinnitus 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 12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21DC011643-01 | NIH | None | httpsreporternihgovquickSearch1R21DC011643-01 |