Clinical trial · Interventional
Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Role of the Sympathetic Nervous System (ANS) Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF (Tumor Necrosis Factor) - a Monocentric Cross-sectional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe. This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VistaO2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- high fatigue
- description
- Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 \<3.2 with visual analog scale of fatigue is \> 5
- interventionNames
- Device: VistaO2
- type
- OTHER
- label
- low fatigue
- description
- Measure of ANS by VistaO2 device in Rheumatoid arthritis (RA) patients with low disease activity according to DAS28 \<3.2 with visual analog scale of fatigue is \< or equal to 5
- interventionNames
- Device: VistaO2
Primary outcomes (1)
- measure
- Ratio low/high frequencies of power spectral density of R-R intervals
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria : * RA diagnosis according to ACR/EULAR 2010 * RA with low disease activity according to DAS28 \< 3.2 * Written consent obtained Exclusion Criteria : * Other diagnosis than RA * Depression known * Hypertension treated or not, * Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy, * Pregnant or breastfeeding women, * Inability to go two consecutive days at the North hospital for the delivery and return of the Vista02 device
References
Publications (0)
Data not yet available