Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain

NCT05186259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-01-09

No results posted yet for this study

Summary

This is a cross-sectional investigation into modulating mechanisms in patients with chronic subjective tinnitus, which will compare 4 patient groups namely chronic tinnitus with chronic pain, chronic tinnitus without chronic pain, chronic pain without tinnitus and healthy controls.

Conditions

Interventions

DIAGNOSTIC_TEST

Self-reported signs of central sensitization

Self-reported signs of central sensitization by means of the Central Sensitization Inventory (questionnaire)

DIAGNOSTIC_TEST

Objective signs of central sensitization

Objective signs of central sensitization by means of Quantitative Sensory Testing (mechanical and heat detection and pain thresholds, endogenous pain facilitation and inhibition)

DIAGNOSTIC_TEST

Audiological outcome measures (audiometry, tinnitus analysis, uncomfortable loudness) in tinnitus patients with and without pain

* Audiometry Performance of pure tone audiometry according to the modified Hughson-Westlake method * Tinnitus analysis Measurement of psychoacoustic features of tinnitus, including (1) tinnitus pitch, (2) loudness, (3) masking ability, and (4) residual inhibition. * Uncomfortable Loudness measures Performance of Uncomfortable Loudness measurements to evaluate the presence of hyperacusis. .

DIAGNOSTIC_TEST

Cognitive functioning

Evaluation of cognitive functioning by means of: * Auditory Stroop test * Detecting letters task * Letter-number sequencing task

DIAGNOSTIC_TEST

Listening effort

Evaluation of listening effort by means of the modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018) .

DIAGNOSTIC_TEST

Self-reported psychological factors

Evaluation of psychological factors by means of: * Depression, Anxiety and Stress Scale (DASS-21) * Beck Depression Inventory (BDI) * Big Five Inventory (BFI) * Connor-Davidson Resilience Scale

DIAGNOSTIC_TEST

Self-reported lifestyle factors

Evaluation of lifestyle factors by means of: Baecke Questionnaire Pittsburg Sleep Quality Index Insomnia Severity Index Stress subscale of the DASS 21

DIAGNOSTIC_TEST

Self-reported measure of pain processing

Evaluation of self-reported pain processing by means of the Pain Catastrophizing Scale

DIAGNOSTIC_TEST

Self-reported quality of life

Self-reported quality of life by means of the SF-36 questionnaire

DIAGNOSTIC_TEST

Self-reported tinnitus severity and impact on daily life

Evaluation of self-reported tinnitus severity and impact on daily life by means of the Tinnitus Functional Index

DIAGNOSTIC_TEST

Self-reported hyperacusis

Evaluation of self-reported characteristics of hyperacusis by means of the Hyperacusis Questionnaire

DIAGNOSTIC_TEST

Self-reported tinnitus characteristics

Evaluation of self-reported tinnitus characteristics by means of the Tinnitus Sample Case History Questionnaire

DIAGNOSTIC_TEST

Self reported neck pain related disability

Evaluation of self-reported neck pain related disability using the Neck Disability Index

Sponsors & Collaborators

  • Bijzonder onderzoeksfonds (BOF)

    collaborator UNKNOWN
  • University Ghent

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186259 on ClinicalTrials.gov