Clinical trial NCT04661995: Notched Noise Therapy for Suppression of Tinnitus
Official title: Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tinnitus
Notched Noise Therapy
Keywords: Tinnitus
Notched Noise Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-12-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A formal randomized controlled trial assessing Amplification + Notched-Noise Therapy (NNT), Amplification + Broadband Noise (BBN), or Amplification-Only (A-O) as treatments for tinnitus will be conducted. 108 participants will be tested on four occasions: baseline, and 4, 8, and 12 weeks post-baseline. Sound delivery for all participants will be accomplished using hearing aids to stream the custom notched noise filter software to the device. These participants will use the devices during most/all waking hours for 8 weeks and will be blinded to the type of stimulus they are receiving. Participants in all three groups will complete outcome measures at week 0 (baseline), week 4 (first in-course assessment), and week 8 (final in-course assessment). Treatment will be discontinued after 8 weeks, with a follow-up assessment at 12 weeks.
Primary purpose: TREATMENT

Brief summary: Tinnitus ("ringing in the ears") has long been a problem for Veterans. The problem continues to escalate due to high levels of noise in the military, and because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder. In spite of limited research support, sound-based (acoustic) therapies are most often used for tinnitus intervention, and increasing numbers of commercial devices are becoming available that offer various acoustic-stimulus protocols. The proposed study will provide evidence from a randomized controlled trial comparing effects of acoustic-stimulus methods that are purported to suppress tinnitus and/or reduce its functional effects. The study will focus on methods with the strongest scientific rationale, i.e., noise that is notched around the predominant tinnitus-frequency region. Special ear-level devices will deliver these acoustic-therapy protocols that are purported to modify tinnitus-related neural activity. The study will follow a study recently completed by the applicant that provides preliminary evidence supporting this method.

Detailed description: Tinnitus is the most prevalent service-connected disability for Veterans. Many Veterans are offered sound-based (acoustic) therapy for tinnitus that is intended to alter the tinnitus perception and/or reactions to tinnitus in a clinically beneficial way. Various methods of acoustic therapy are in use and companies are promoting different products. It remains unknown; however, how certain acoustic parameters may be more effective than others. Recent research has shown the benefit of one such acoustic therapy, Notched Noise Therapy, that presents wideband sound with the tinnitus frequency region notched out, theorized to distribute lateral inhibition into the notched frequency region to suppress neural activity believed to cause the tinnitus percept. Previous studies have typically involved brief daily exposures, which are not as likely to remodel neural processes underlying tinnitus as is continuous "immersion" in background sound, which is adopted here. The proposed study will conduct a randomized controlled trial to evaluate the efficacy of notched noise therapy (NNT). The long-term goal of the research program is to develop an accessible, evidence-based treatment that reduces tinnitus loudness and to be able to assess that treatment through a validated method of behavioral and physiological clinical tools. The overall objective for this CDA-2 research plan, which is the next step toward attainment of the investigators' long-term goal, is to systematically evaluate the utility of functional, psychoacoustic, and electrophysiologic measures to reveal the overall whole-health impact in Veterans with chronic tinnitus. The trial will enroll 108 participants, who will be randomized to one of three acoustic therapy methods: amplification + notched noise, amplification + noise without notch, and amplification-only. The three groups will be asked to wear ear-level devices (combination instruments that provide both amplification and 1-10 kHz shapeable noise) as much as possible during waking hours. All participants will undergo acoustic therapy for 8 weeks and will complete outcome measures (i.e., Tinnitus Functional Index, Psychoacoustic loudness and pitch matches, AEP, and EEG measures) at baseline and at 4 and 8 weeks. They will repeat outcome assessment at 12 weeks to evaluate for maintenance of any effects while not receiving acoustic therapy for 4 weeks. (Participants requiring hearing aids for hearing loss will continue to use their aids during the 4-week no-treatment period). The investigators hypothesize that NNT suppresses tinnitus perception by distributing lateral inhibition into the notched frequency region and will therefore, reduce the perception of tinnitus loudness. At the completion of this CDA-2 program, the expected outcomes include a NNT as a therapy for tinnitus and the contributions that it may have on tinnitus perception as well as a solid training foundation for a successful VA research career. These results are expected to have an important positive impact because they will not only provide insight into the true reactionary and perceptual benefit of an intervention, but a treatment evaluation protocol will be determined, ultimately providing a foundation for the development of evidence-based acoustic therapies to treat tinnitus, a critical component and goal of Veteran tinnitus care.

Eligibility criteria: Inclusion Criteria:

Candidates must meet the following inclusion criteria to qualify:

* Veteran
* no active middle-ear disease
* at least one air conduction hearing threshold of 40 dB HL or worse in each ear between .25-8 kHz as measured at the first study visit
* unilateral or bilateral constant tinnitus
* index score on the Tinnitus Functional Index (TFI) of at least 25 (out of a maximum score of 100)
* a score of 24 or higher on the Mini Mental State Exam (MMSE)
* a tinnitus pitch match between 2-10 kHz (and achieve desired level of precision as described below in 3.3 Study Procedures, Tinnitus Psychoacoustic Assessment)
* demonstrates understanding of the requirements of the study
* motivated and capable of participating (including ability to communicate in English)

Exclusion Criteria:

The following exclusion criteria will be used:

* two or more hearing thresholds exceeding 70 dB HL
* significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 15 dB at any one frequency
* suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus potentially related to temporo-mandibular disorder or whiplash (any of which can be ruled out with an examination by an appropriate physician)
* any mental, emotional, or health conditions that would preclude full study participation

Primary outcomes:
measure: Change of Tinnitus Functional Index Scores from Baseline at 4 weeks, 8 weeks, and 12 weeks
timeFrame: 4 time points/visits: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change of Tinnitus Loudness Match from Baseline at 4 weeks, 8 weeks, and 12 weeks
timeFrame: 4 time points/visits: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
measure: Change of Electroencephalography (EEG) power in delta, theta, alpha, beta, and gamma bands from Baseline to 8 weeks
timeFrame: 2 time points/visits: Baseline, 8 weeks
measure: Change of N100, P200, and P300 Auditory Evoked Potentials (AEPs) from Baseline to 8 weeks
timeFrame: 2 time points/visits: Baseline, 8 weeks
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Candice Manning Quinn, PhD AuD
role: PRINCIPAL_INVESTIGATOR
References: