Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 6:15 PM
Study NCT ID:
NCT05186259
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2021-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Sponsor:
University Ghent
Organization:
Study Overview
Official Title:
Modulating Mechanisms in Patients With Chronic Subjective Tinnitus and/or Chronic Pain
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The first aim is to investigate differences in pain-related factors, psychological factors, lifestyle factors and tinnitus-related factors in patients with chronic subjective tinnitus and the comparison with patients suffering from both chronic subjective tinnitus and chronic musculoskeletal pain, chronic musculoskeletal pain only and healthy controls. The primary outcome measures will be pain-related factors and correlations will also be calculated between pain-related factors on the one hand and psychological factors, lifestyle factors and tinnitus-related factors on the other hand.
A second aim is to assess contributing factors to tinnitus severity (measured by the Tinnitus Functional Index) in patients with tinnitus with or without chronic pain. Contributing factors will include pain-related factors, psychological factors, lifestyle factors, and tinnitus-related factors, audiological factors, cognitive factors.
* Pain-related factors include:
1. Self-perceived symptoms of central sensitization by means of the Central Sensitization Inventory: The Central Sensitization Inventory is a self-report questionnaire that assesses clinical symptoms indicative for central sensitization.
2. Experimental measures of central sensitization: Quantitative Sensory Testing Quantitative Sensory Testing (QST) is a psychophysiological assessment of sensory pathways including mechanicaldetection and pain thresholds, cutaneous heat detection and pain thresholds, and endogenous pain facilitation and inhibition.
3. Self-reported pain processing by means of the Pain Catastrophizing Scale
4. Self-reported neck pain related disability by means of the Neck Disability Index
* Psychological factors include:
Self-reported stress, anxiety and depression (Depression, Anxiety and Stress Scale\_21 and Beck Depression Inventory), resilience (Connor Davidson Resilience Scale), personality (Big Five Index)
\*Lifestyle factors include:
Self-reported physical activity (Baecke Questionnaire), self-reported sleep quality (Pittsburgh Sleep Quality Index) and self-reported insomnia severity (Insomnia Severity Index), self-reported quality of life (SF-36)
\*Tinnitus-related factors include:
Self-reported tinnitus severity and impact (Tinnitus Functional Index), self-reported hyperacusis (Hyperacusis Questionnare), self-reported tinnitus characteristics (Tinnitus Sample Case History Questionnaire)
* Cognitive factors include:
1. Verbal working memory capacity and processing speed (Letter-number sequencing task)
2. Attention span (detecting letters-task (COTESS))
3. Cognitive flexibility and inhibition (Auditory Stroop task)
4. Listening effort (Modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018))
* Audiological factors include:
1. Hearing thresholds (Pure tone audiometry)
2. Psychoacoustic features of tinnitus (tinnitus pitch, loudness, masking ability, and residual inhibition using same devices as for pure tone audiometry)
3. Uncomfortable Loudness (using same devices as for pure tone audiometry)
A second aim is to assess contributing factors to tinnitus severity (measured by the Tinnitus Functional Index) in patients with tinnitus with or without chronic pain. Contributing factors will include pain-related factors, psychological factors, lifestyle factors, and tinnitus-related factors, audiological factors, cognitive factors.
* Pain-related factors include:
1. Self-perceived symptoms of central sensitization by means of the Central Sensitization Inventory: The Central Sensitization Inventory is a self-report questionnaire that assesses clinical symptoms indicative for central sensitization.
2. Experimental measures of central sensitization: Quantitative Sensory Testing Quantitative Sensory Testing (QST) is a psychophysiological assessment of sensory pathways including mechanicaldetection and pain thresholds, cutaneous heat detection and pain thresholds, and endogenous pain facilitation and inhibition.
3. Self-reported pain processing by means of the Pain Catastrophizing Scale
4. Self-reported neck pain related disability by means of the Neck Disability Index
* Psychological factors include:
Self-reported stress, anxiety and depression (Depression, Anxiety and Stress Scale\_21 and Beck Depression Inventory), resilience (Connor Davidson Resilience Scale), personality (Big Five Index)
\*Lifestyle factors include:
Self-reported physical activity (Baecke Questionnaire), self-reported sleep quality (Pittsburgh Sleep Quality Index) and self-reported insomnia severity (Insomnia Severity Index), self-reported quality of life (SF-36)
\*Tinnitus-related factors include:
Self-reported tinnitus severity and impact (Tinnitus Functional Index), self-reported hyperacusis (Hyperacusis Questionnare), self-reported tinnitus characteristics (Tinnitus Sample Case History Questionnaire)
* Cognitive factors include:
1. Verbal working memory capacity and processing speed (Letter-number sequencing task)
2. Attention span (detecting letters-task (COTESS))
3. Cognitive flexibility and inhibition (Auditory Stroop task)
4. Listening effort (Modified version of the behavioral listening effort test based on a dual-task paradigm by Degeest, Keppler \& Corthals (2018))
* Audiological factors include:
1. Hearing thresholds (Pure tone audiometry)
2. Psychoacoustic features of tinnitus (tinnitus pitch, loudness, masking ability, and residual inhibition using same devices as for pure tone audiometry)
3. Uncomfortable Loudness (using same devices as for pure tone audiometry)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: