Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus
NCT04717388, Not applicable, Recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus | ClinicalTrials.gov |
| NCT number | NCT04717388 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Tinnitus, Epilepsy, Temporal Lobe | ClinicalTrials.gov |
| Interventions | acoustics tests, Questionaries,, MRI | ClinicalTrials.gov |
| First posted | 2021-01-22 | ClinicalTrials.gov |
| Last updated | 2024-12-12 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluation of the impact of tinnitus on executive cognitive functioning | at the second visit, maximum 6 month after first visit. | Measurement of executive control using a stroop test in people with and without chronic tinnitus. | ClinicalTrials.gov |
| Secondary | Emotional functioning (anxiety and depression) | at the second visit, maximum 6 month after first visit. | Measures of Anxiety and Depression using: Hospital Anxiety and Depression Scale (HADS) : 14 rated items from 0 to 3. Seven questions are related to anxiety and seven to the depressive dimension, allowing for thus obtaining two scores (maximum score of each score = 21). | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : \- Self-assessment questionnaires for hearing loss: The self-assessment of hearing loss is based on a yes/no question: "Do you feel that you have a hearing loss or hearing loss? | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : \- The noise hypersensitivity questionnaire( Khalfa, 2002) provides a score ranging from 0 (no hypersensitivity) to 42 (very strong hypersensitivity). | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : \- The severity of tinnitus is measured by the Tinnitus Handicap Inventory (THI) questionnaire. Scores range from 0 (mild discomfort) to 100 (catastrophic impact). | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : \- Hearing threshold measurement (pure tones from 125-16000Hz) | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : \- Discomfort threshold measurement (with 1kHz sound) | ClinicalTrials.gov |
| Secondary | psycho-acoustic functioning | at the second visit, maximum 6 month after first visit. | Measurements of auditory functioning through hearing assessment (audiometry) : Evaluation of transient otoacoustic emissions (TEOAE) or by distortion product (DPOAE) | ClinicalTrials.gov |
| Secondary | cognitive functioning, other than executive functioning (attention, memory) | at the second visit, maximum 6 month after first visit. | Measures of cognitive functioning : \- the Attentional Network Test (ANT) visual attention test. ANT gives three attention scores based on reaction times. These scores represent the ability to direct attention, to be alert to surrounding stimuli and the executive part of attention. | ClinicalTrials.gov |
| Secondary | cognitive functioning, other than executive functioning (attention, memory) | at the second visit, maximum 6 month after first visit. | Measures of cognitive functioning : \- Mental Flexibility Score (Trail Making Test): The scores of the TMT (Trail Making Test) are expressed in time of completion. The faster the time to completion, the better the performance. So we have 2 scores, one for board A of the test: TMT-A and the other for board B of the test: TMT-B. | ClinicalTrials.gov |
| Secondary | cognitive functioning, other than executive functioning (attention, memory) | at the second visit, maximum 6 month after first visit. | Measures of cognitive functioning : Measures of cognitive functioning :- Short-term memory score (auditive-verbal span). Score between 1 and 10, where 10 represents the best short-term memory score | ClinicalTrials.gov |
| Secondary | cognitive functioning, other than executive functioning (attention, memory) | at the second visit, maximum 6 month after first visit. | Measures of cognitive functioning : Measures of cognitive functioning :- Working memory score (Brown-Peterson). The Brown Peterson gives a memorization score ranging from 0 to 100, where 100% is the best score. | ClinicalTrials.gov |
| Secondary | cognitive functioning, other than executive functioning (attention, memory) | at the second visit, maximum 6 month after first visit. | Measures of cognitive functioning : \- Episodic memory score in auditory modality. The episodic memory test in auditory mode gives a memorization score ranging from 0 to 100, where 100% represents a perfect memorization score. | ClinicalTrials.gov |
| Secondary | the reorganization of functional and structural brain connectivity maps | at the third visit, maximum 18 month after the first visit | Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) : \- Volumetric measurement (in particular of the amygdala and the parahippocampal cortex) | ClinicalTrials.gov |
| Secondary | the reorganization of functional and structural brain connectivity maps | at the third visit, maximum 18 month after the first visit | Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) : \- Measurement of anatomical connections between regions of interest (i.e. amygdala, auditory cortex, attention network including the precuneus and prefrontal cortex) from diffusion tensor imaging (TDI): fractional anisotropy (FA), mean diffusivity (MD), radial (RD) and axial (AD). | ClinicalTrials.gov |
| Secondary | the reorganization of functional and structural brain connectivity maps | at the third visit, maximum 18 month after the first visit | Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) : \- Measurement of structural connectivity from fMRI at rest between predefined regions of interest and over new regions of interest defined during an attentional activation task | ClinicalTrials.gov |
| Secondary | the reorganization of functional and structural brain connectivity maps | at the third visit, maximum 18 month after the first visit | Functional and structural brain connectivity measurements using brain imaging (fMRI, diffusion and resting MRI) : \- Measurement of the amplitude of the synchrony of slow fluctuations and statistical dependencies in functional connectivity by comparing data from people with and without chronic tinnitus. | ClinicalTrials.gov |
| Secondary | Emotional functioning (stress) | at the second visit, maximum 6 month after first visit. | Measures of stress using Perceived Stress Scale (PSS-4): Lowest score: 0, Highest score: 16, Higher scores are correlated to more stress. | ClinicalTrials.gov |
| Secondary | Emotional functioning (Auditory recognition of emotions) | at the second visit, maximum 6 month after first visit. | Measures of Auditory recognition of emotions using hearing tests with recordings | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | 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 |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Attention Network Test | Secondary outcome | ConductCognition |
| Brown-Peterson Task | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
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.