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Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants
trial testing Cochlear Implants in Cochlear Implants in 8 participants. Completed in 31 March 2022.
| Lead sponsor | Father Flanagan's Boys' Home |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8 |
| Start date | 2 August 2021 |
| Primary completion | 31 March 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 1 location across United States |
Father Flanagan's Boys' Home
Adults 19 to 80, any sex, with Cochlear Implants. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The metric for speech recognition is the percentage of Perceptually Robust English Sentence Test Open-set (PRESTO) sentence keywords that were correctly repeated in order.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 62 | 30 – 80 |
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 22 | 9 – 28 |
The metric for temporal modulation detection is the modulation depth relative to 100% modulation which the participant can detect 71% of the time.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | -3.1 | -6.2 – -0.4 |
The metric for spectral modulation detection is the magnitude of the peak-to-valley ratio of the spectrally modulated stimulus which the participant can detect 71% of the time.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 12.8 | 4.8 – 34 |
The outcome is the percentage of letters recalled in the correct position across all trials, out of a total of 75 letters.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 57 | 33 – 91 |
The outcome is the total percentage of digits recalled in the correct position across all trials, out of a maximum of 220.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 64 | 49 – 92 |
The outcome is the average number of words recalled from each list, with a possible maximum of 12.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 3.3 | 2.1 – 4.8 |
The outcome is the percentage of numbers correctly recalled across boxes, out of a total of 49.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 57 | 18 – 86 |
The outcome is the average number of digits recalled in the correct position relative to the last item in the sequence across lists.
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 2.4 | 1.1 – 3.9 |
The metric for stream segregation is the percent change in digit recall that occurs when voice pitch differs from the distractor digits (85, 120, and 150 Hz) relative to when voice pitch between target and distractor digits is the same (200 Hz).
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 12.5 | -20 – 43 |
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 12.5 | -35 – 43 |
| Group | Value | 95% CI |
|---|---|---|
| Cochlear Implant Recipients | 16 | -8 – 42 |
Individuals with cochlear implants will complete tasks which measure auditory resolution, working memory, stream segregation, and speech recognition in the presence of competing speech using their everyday clinical device settings. The relationship between these tasks will be examined to identify the factors which predict successful speech recognition in the presence of competing speech.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing