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 predictable and unpredictable sounds affects tinnitus characteristics. Hypotheses: Administration of unpredictable sound therapy will result in lower tinnitus loudness and distress outcomes than predictable 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 was a randomized control trial with a cross-over design involving the use of take home MP3 players and in-ear phones, containing recorded predictable and unpredictable tinnitus relief sounds, which the participant listened to for a minimum of one hour per day for sixteen weeks (8 weeks predictable, 8 weeks unpredictable sounds). All stimuli (predictable and unpredictable sounds) were adjusted for sound level such that long-term average loudness (dB SPL) was equivalent. There was a thr
This study was a randomized control trial with a cross-over design involving the use of take home MP3 players and in-ear phones, containing recorded predictable and unpredictable tinnitus relief sounds, which the participant listened to for a minimum of one hour per day for sixteen weeks (8 weeks predictable, 8 weeks unpredictable sounds). All stimuli (predictable and unpredictable sounds) were adjusted for sound level such that long-term average loudness (dB SPL) was equivalent. There was a three week wash-out period in between the two conditions. 13 participants were administered the Predictable condition first and 12 participants administered the Unpredictable condition first. All participants were tested by the student investigator throughout the trial. Adherence to intervention was monitored by email communication every two weeks (beginning with the date of sound fitting) which asked participants how the sound trial was going, if they have any concerns or queries, any special circumstances, etc. In-between follow-up appointments were made as needed. The interviews at each follow-up appointment also monitored adherence and addressed any concerns which arose. Predictable sound therapy a) Broadband noise (BBN) set at the volume such that it was comfortable, and at the minimal level at which the sound started to interfere with their tinnitus. b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks d) Mode of administration: MP3 file participants listened to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear phones (RP-HJE290) with Budloks Sport Grip Unpredictable sound therapy a) Beach surf, Cicadas/Farm Sounds and Rain sounds directly recorded from the natural setting by the researchers and edited. Participants selected which sound they preferred to use in the trial. In use participants were asked to set the volume of sound such that it was comfortable, and at the minimal level at which the sound started to interfere with their tinnitus. b) Frequency of stimulation: Minimum 1 hour per day for 8 continuous weeks d) Mode of administration: MP3 file participants listened to using a Phillips ViBe 4GB MP3 player + Panasonic in-ear phones (RP-HJE290) with Budloks Sport Grip
Sponsors
Mithila Durai
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 or over 65 - 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