Trial · NCT07371299
Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
NCT07371299, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation. Trials, record NCT07371299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07371299
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
- NCT number
- NCT07371299
- Status
- Not yet recruiting
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Severe to Profound Sensorineural Hearing Loss
- Interventions
- Objective electrophysiological measures (eCAP, eABR, eSRT)
- First posted
- 2026-01-27
- Last updated
- 2026-01-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The MCL threshold, the objective response threshold (eSRT), the eSRT response | 15 months | "The MCL threshold, expressed in CU (charge unit) units, corresponds to the maximum level of stimulation of the implant required to obtain a sound level considered comfortable by the patient. It will be recorded at each post-operative check-up (M1, M3, M6, M9, and M12). The objective response threshold (eSRT), expressed in CU units, corresponds to the minimum level of implant stimulation required to elicit a stapedial reflex. It will be recorded at each post-operative assessment (M1, M3, M6, M9, and M12). The eSRT response will be collected using a tympanometry probe (commonly used to measure ear impedance in patients during a standard hearing assessment) in the patient's external auditory canal, ipsilateral or contralateral to the implanted side. The tympanometer will continuously record ear impedance during electrical stimulation until a significant variation is obtained, indicating the presence of the stapedial reflex." |
| Secondary | Correlation between behavioral MCL and eABR threshold | Month 6 and Month 12 post-operative follow-up visits (incident cohort) | Pearson/Spearman correlation between Maximum Comfortable Level (MCL, charge units \[CU\]) and electrically evoked Auditory Brainstem Response (eABR) threshold (CU); measured on ≥3 electrodes (basal, middle, apical) using standard CI programming and evoked-potential equipment. |
| Secondary | Correlation between behavioral MCL and eCAP threshold | M1, M3, M6, M9, M12 post-operative visits (incident cohort). | Pearson/Spearman correlation between MCL (CU) and electrically evoked Compound Action Potential (eCAP) threshold (CU); measured on ≥3 electrodes (basal, middle, apical) via implant software. |
| Secondary | Correlation between eSRT and eABR thresholds | M6 and M12 post-operative visits (incident cohort). | Pearson/Spearman correlation between electrically evoked Stapedius Reflex Threshold (eSRT, CU) and eABR threshold (CU); ≥3 electrodes per visit. |
| Secondary | Correlation between eSRT and eCAP thresholds | M1, M3, M6, M9, M12 post-operative visits (incident cohort). | Pearson/Spearman correlation between eSRT (CU) and eCAP threshold (CU); ≥3 electrodes per visit. |
| Secondary | Correlation between eABR and eCAP thresholds | Month 6 and Month 12 after cochlear implantation (incident cohort) | Pearson/Spearman correlation between eABR and eCAP thresholds (both in CU); ≥3 electrodes per visit. |
| Secondary | Agreement between intraoperative eSRT by tympanometer vs visual stapedius reflex | ntraoperative (single time point during CI surgery). | Association between peri-operative eSRT measured objectively with a tympanometer and the surgeon's visual observation of stapedius movement (yes/no). |
| Secondary | Probe frequencies eliciting eSRT | Post-operative follow-up visits at Month 1, Month 3, Month 6, Month 9, and Month 12 (incident cohort), and 1 year or more after cochlear implantation (prevalent cohort) | Distribution of probe frequencies (226, 678, 1000 Hz) that yield an eSRT response; eSRT level recorded for each tested frequency. |
| Secondary | Longitudinal profile of objective thresholds (eSRT/eABR/eCAP) | From Month 1 to Month 12 after cochlear implantation (incident cohort) | Trajectory of eSRT, eABR, and eCAP thresholds over the first post-operative year, summarized graphically and descriptively. |
| Secondary | Cross-sectional associations among MCL and objective measures in prevalent users | At the annual follow-up visit, at least 12 months after cochlear implant surgery. | Correlations between MCL and eSRT/eABR/eCAP, and pairwise correlations among objective measures, in adults with ≥12 months of CI use. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07371299
GET https://conductscience.org/api/trials/v1/NCT07371299/registered