Phase 3
N=100
Evaluation of the CR Neuromodulation Treatment for Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT01541969 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Tinnitus Handicap Questionnaire (THQ) — 3.75; 4.02 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CR Neuromodulation (Device); Tinnitus masking (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nottingham University Hospitals NHS Trust
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Handicap Questionnaire (THQ) |
5.41; 6.01 | — |
| SECONDARY Tinnitus Handicap Inventory (THI) |
2.84; 1.64 | — |
| SECONDARY Tinnitus Functional Index (TFI) |
2.38; 4.45 | — |
| SECONDARY World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) |
-0.21; -0.11 | — |
| SECONDARY Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG) |
0.001; 0.004 | — |
| SECONDARY Tinnitus Handicap Questionnaire (THQ) |
5.41; 6.01 | — |
Summary
The purpose of this study is to determine whether a new device delivering a sound-based intervention (termed acoustic coordinated reset neuromodulation) has significant clinical benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of sound stimulation delivered by the device acts to break up patterns of synchronous nerve firing in the brain that may be responsible for the sensation of tinnitus. We will also measure brain activity in a subset of participants to determine if the intervention results in changes in brainwave activity.
Eligibility Criteria
Inclusion Criteria
- Pure tone average 70 dB on individual frequencies up to 8 kHz (unable to sufficiently hear the stimulus)
- Taking part in another trial during the last 30 days before study start
- The individually tailored training stimulus is uncomfortable or not acceptable to the participant
Data sourced from ClinicalTrials.gov (NCT01541969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.