Clinical trial
Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial
Name
C3281-W
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2026-05-31
Trial end
2026-05-31
Treatment
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.
Arms:
Amplification + Notched Noise Therapy
Other names:
HA + NNT
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.
Arms:
Amplification + Broadband Noise
Other names:
HA + BBN
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.
Arms:
Amplification Only
Other names:
A-O
Size
108
Primary endpoint
Change of Tinnitus Functional Index Scores from Baseline at 4 weeks, 8 weeks, and 12 weeks
4 time points/visits: Baseline, 4 weeks, 8 weeks, 12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}
Updated at
2023-10-05
1 organization
Organization
VA Office of Research and Development