Notched Noise Therapy for Suppression of Tinnitus
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|ClinicalTrials.gov Identifier: NCT04661995|
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : August 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus Notched Noise Therapy||Combination Product: Hearing Aid and Notched Noise Therapy Combination Product: Hearing Aid and Broadband Noise Device: Hearing Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking Description:||Participants in all three groups will be blinded to the randomization of tinnitus treatment. Three treatment groups are identified: Amplification + Notched Noise Therapy; Amplification + Broadband Noise (white noise); and Amplification Only. Participants will be blinded to the treatment they are receiving so that results of perceptual change of subjective tinnitus can be truly measured with validated, evidence-based outcome measures.|
|Official Title:||Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial|
|Estimated Study Start Date :||January 3, 2022|
|Estimated Primary Completion Date :||May 31, 2026|
|Estimated Study Completion Date :||May 31, 2026|
Experimental: Amplification + Notched Noise Therapy
Following the baseline assessment, participants will be randomly assigned to one of the study groups. This treatment group will include a Notched Noise Therapy, a 1-10 kHz noise "notched" within a 1-octave range centered around the psychoacoustic tinnitus pitch match measured. Randomized participants will wear their hearing aids with this loaded software for 8 weeks. They will be seen at a baseline, 4 week, and 8 week visits for outcome measures and any adjustments in hearing aid comfort.
Combination Product: Hearing Aid and Notched Noise Therapy
Notched Noise Therapy involves presenting wide-band sound with the tinnitus frequency region notched out, referred to as notched noise, or notch therapy. This procedure may distribute lateral inhibition into the notched frequency region, suppressing tinnitus neural activity believed to be occurring there. This type of therapy is provided through a sound file that is streamed through hearing aids.
Other Name: HA + NNT
Active Comparator: Amplification + Broadband Noise
Following the baseline assessment, participants will be randomly assigned to one of the study groups. A popular and commonly used sound therapy treatment, this treatment group will listen to a broadband noise, or "white noise," that is housed on the manufacturer's hearing aid tinnitus program. They will be seen at a baseline, 4 week, and 8 week visits for outcome measures and any adjustments in hearing aid comfort.
Combination Product: Hearing Aid and Broadband Noise
Broadband Noise, or "white noise," is a common tinnitus sound therapy treatment option. It is also commonly used as a "masker" noise for individuals with tinnitus that like to enrich their environment with sound.
Other Name: HA + BBN
Placebo Comparator: Amplification Only
Following the baseline assessment, participants will be randomly assigned to one of the study groups. Hearing aids are ear-level, self-contained, FDA-approved hearing device. Hearing aids help individuals with hearing loss and provide safe amplification/gain to frequencies that have loss.
Device: Hearing Aid
A-O groups will use ear-level, self-contained devices (hearing aids) that (1) are capable of streaming shapeable broadband noise between 1-10 kHz; (2) allow for normal conversation; and (3) are comfortable, easy to use, and discrete. These criteria describe a behind-the-ear hearing aid with the capability of streaming custom sounds. Hearing aids are used to provide amplification to those with hearing loss and are fit by licensed audiologists. Sometimes, hearing aids can provide benefit to those with bothersome tinnitus.
Other Name: A-O
- Change of Tinnitus Functional Index Scores from Baseline at 4 weeks, 8 weeks, and 12 weeks [ Time Frame: 4 time points/visits: Baseline, 4 weeks, 8 weeks, 12 weeks ]The TFI is useful in both clinical and research settings because of its excellent responsiveness to treatment-related change, its high construct validity for scaling the overall severity of tinnitus, and its comprehensive coverage of the negative impacts of tinnitus (Meikle, et al., 2012; Henry, Griest et al., 2016). Participants will complete the TFI at each appointment prior to any audiometric or psychoacoustic testing.
- Change of Tinnitus Loudness Match from Baseline at 4 weeks, 8 weeks, and 12 weeks [ Time Frame: 4 time points/visits: Baseline, 4 weeks, 8 weeks, 12 weeks ]For tinnitus loudness match, participants will be seated facing a computer monitor and shown how to use the TES Module (device with a knob and four buttons) to respond to acoustic signals presented through Etymotic ER-4B insert earphones. Test frequencies include 0.25-16 kHz in 1/3-octave intervals. Participants will complete the Tinnitus Loudness Match at each appointment to identify change in loudness perception.
- Change of Electroencephalography (EEG) power in delta, theta, alpha, beta, and gamma bands from Baseline to 8 weeks [ Time Frame: 2 time points/visits: Baseline, 8 weeks ]30 participants (10 from each study arm) will be randomized into a supplemental group to receive extra testing: EEG assessment. EEG will be recorded using an Electro-Cap International, Inc. cap housing 64 Ag/AgCl electrodes and the Neuroscan recording system. Responses from all 64 electrode channels will be available for analysis, thus allowing for identification of channels with the strongest responses. Data will be re-sampled to 128 Hz, band-pass filtered to 2-44 Hz and subsequently transposed, plotted, and carefully inspected for manual artifact rejection and epochs containing excessive artifacts will be removed. Average Fourier cross-spectral matrices will be computed for bands delta (2-3.9 Hz), theta (4-7.9 Hz), alpha1 (8-9.9 Hz), alpha 2 (10-12.9 Hz), beta1 (13-18.4 Hz), beta2 (18.5-21.4 Hz), beta3 (21.5-30.4 Hz), and gamma (30.5-44 Hz).
- Change of N100, P200, and P300 Auditory Evoked Potentials (AEPs) from Baseline to 8 weeks [ Time Frame: 2 time points/visits: Baseline, 8 weeks ]Two different AEP protocols will be used to assess neural activity associated with auditory attention in this subset of study participants (10 from each arm) at two timepoints: baseline and after 8 weeks of amplification with or without additional sound therapy. AEPs will be recorded using an Electro-Cap International, Inc. cap housing 64 Ag/AgCl electrodes and the Neuroscan recording system. The two AEP protocols are: (1) A paired-click P50 paradigm will be used to assess auditory habituation, which is part of the process of sensory gating. (2) An auditory P300 paradigm will be used to assess higher-level attentional mechanisms. Stimuli will include 500 Hz pure tones (frequent stimulus) and 1000 Hz pure tones (rare stimulus). During this protocol, AEP components N100, P200, and P300 will be recorded and analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661995
|Contact: Candice M Quinn, PhD AuD||(503) 220-8262 ext 52448||Candice.Quinn@va.gov|
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Candice Manning Quinn, PhD AuD||Durham VA Medical Center, Durham, NC|