Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation
NCT04063748, Not applicable, Unknown, Universitaire Ziekenhuizen KU Leuven
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT04063748 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven | ClinicalTrials.gov |
| Conditions | Hearing Disability | ClinicalTrials.gov |
| Interventions | Audiological rehabilitation, Placebo Rehabilitation, Passive Control | ClinicalTrials.gov |
| First posted | 2019-08-21 | ClinicalTrials.gov |
| Last updated | 2023-02-17 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Speech in noise intelligibility | Change at 16 wks compared to baseline | LIST sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST, (van Wieringen \& Wouters, 2008)) was specifically designed for speech perception in noise assessment in CI users. The test has a high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech. discrimination in noise. Therefore, the primary endpoint to validate the LUISTER AR scheme will be an improvement of 2dB on speech discrimination in noise. | ClinicalTrials.gov |
| Secondary | Executive functioning inhibition | 16 weeks, + 6 months | Stroop test | ClinicalTrials.gov |
| Secondary | Executive functioning: task switching | 16 weeks, + 6 months | Trail Making A-B | ClinicalTrials.gov |
| Secondary | Executive functioning updating | 16 weeks, + 6 months | letter memory task | ClinicalTrials.gov |
| Secondary | Fluid intelligence | 0 weeks, for baseline | Matrix reasoning (WAIS test) | ClinicalTrials.gov |
| Secondary | Self-reported measure | 0 and 16 weeks, + 6 months | Nijmegen CI Questionnaire (NCIQ): 5-points scale assesses communication and quality. of life in persons with a cochlear implant. There are 6 subdomains, ranging from 0 (low) to 100 (high). Subdomains are evaluated by adding together the scores of each questions per subdomain and dividing this by the number of completed items per subdomain. A total score is reported. | ClinicalTrials.gov |
| Secondary | Self-reported measure | 0 weeks, for baseline | Coping: Utrechtse Coping Lijst: A validated questionnaire based on a 4-point scale: assesses coping strategies in daily life. There are 7 subscales and 1 total score. Scale varies between 1 (low) and 4 (high). | ClinicalTrials.gov |
| Secondary | Transfer of change in speech in noise intelligibility | Change at 6 months post intervention compared to primary outcome | LIST sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST, (van Wieringen \& Wouters, 2008)) was specifically designed for speech perception in noise assessment in CI users. The test has a high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Letter Memory Task | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)