None listed
Conditions
Brief summary
Mechanisms of tinnitus (phantom sound) perception and sound therapy (treating tinnitus using sounds) are still poorly understood. Understanding such mechanisms can enable for developing better interventions/treatments for tinnitus sufferers. It is of interest to administer a randomized control sound therapy trial comparing the effectiveness of predictable and unpredictable sounds for tinnitus relief. It is also of interest to see how the emotional component of sounds may influence its effectiveness as a tinnitus treatment sound. Aim: Understand how sound therapy of long-term duration using broadband noise (BBN) and environmental sounds affects tinnitus characteristics. Hypotheses: Administration of environmental sound therapy will result in lower tinnitus loudness and distress outcomes than BBN sound therapy. Tinnitus treatment sounds which evoke positive, relaxed emotions (high valence) will result in lower tinnitus loudness and distress outcomes than static, neutral sounds.
Interventions
This study will be a randomized cross-over trial. The study will involve the use of take home MP3 players and in-ear headphones, containing recorded broad-band noise (BBN) and environmental sounds for tinnitus relief, which the participant will listen to for a minimum of one hour per day for sixteen weeks (8 weeks BBN, 8 weeks environmental sounds). The long-term average loudness of BBN and environmental sounds will be equivalent. There will be a three week wash-out period in between the two con
This study will be a randomized cross-over trial. The study will involve the use of take home MP3 players and in-ear headphones, containing recorded broad-band noise (BBN) and environmental sounds for tinnitus relief, which the participant will listen to for a minimum of one hour per day for sixteen weeks (8 weeks BBN, 8 weeks environmental sounds). The long-term average loudness of BBN and environmental sounds will be equivalent. There will be a three week wash-out period in between the two conditions. A cross-over trial design will be used to enable repeated measures of both BBN and environmental sound therapies for participants (15 participants: predictable first and 15 participants: unpredictable first). All participants will be tested by the student investigator throughout the trial. BBN sound therapy a) Broadband noise (BBN) set at desired listening level for comfort. Tinnitus will be audible alongside the BBN. b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks d) Mode of administration: MP3 file while participants will listen to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear headphones (RP-HJE290) with Budloks Sport Grip Environmental sound therapy a) Environmental nature sounds (beach surf, rain, cicadas) recorded by the PI and student investigator, which vary in a random manner based one or more of the following: centre frequency, frequency relative to tinnitus, amplitude and modulation rate. Tinnitus will be audible at random time intervals alongside the nature sounds. b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks d) Mode of administration: MP3 file which participants will listen to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear headphones (RP-HJE290) with Budloks Sport Grip Follow-ups appointments were scheduled at two, four and eight weeks post fitting to monitor adherence to the intervention and changes in outcome measures over time.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults aged between 18-65 years residing in the Auckland region with constant tinnitus and a minimum score of 38 on Tinnitus Functional Index (TFI), normal middle ear function and at maximum a moderate degree of hearing loss (less than 70 dB on average across frequencies).
Exclusion criteria
- Age is younger than 18 - Do not experience constant tinnitus - Presence of middle ear pathology at the time of testing (e.g. glue ear) - Presence of a hearing loss greater than moderately severe (greater than 70 dB on average across frequencies).
Outcome results
None listed