Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
United States
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Contact Information
Primary
Candice M Quinn, PhD AuD
Candice.Quinn@va.gov
(919) 286-0411
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 108
Treatments
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.
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.
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.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov