Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF

Rheumatoid Arthritis Clinical Trial

— ANSRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475486
• Other study ID #: 1508054
• Secondary ID: 2015-A00655-44
• Status: Completed
• Phase: N/A
• Start date: February 25, 2016
• Est. completion date: October 8, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fatigue
• Rheumatoid Arthritis

Intervention

Device:
• VistaO2
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio low/high frequencies of power spectral density of R-R intervals	Comparison of Ratio low/high frequencies of power spectral density of R-R intervals between RA patients with low fatigue and RA patients with high fatigue. Ratio low/high frequencies of power spectral density of R-R is measured by VistaO2 device.	day1
Secondary	Number of sleep apnea syndrome	Comparison of Number of sleep apnea syndrome between between RA patients with low fatigue and RA patients with high fatigue. sleep apnea syndrome is measured by VistaO2 device.	day 1
Secondary	Standard deviation of all R-R intervals (SDNN)	Comparison of Standard deviation of all R-R intervals (SDNN) between RA patients with low fatigue and RA patients with high fatigue. Standard deviation of all R-R intervals (SDNN) is measured by VistaO2 device.	day 1
Secondary	Total Power spectral density (PSD)	Comparison of Total Power spectral density (PSD) between RA patients with low fatigue and RA patients with high fatigue. Total Power spectral density (PSD) is measured by VistaO2 device.	day 1
Secondary	PSD of Lower Frequencies	Comparison of PSD of Lower Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of Lower Frequencies is measured by VistaO2 device.	day 1
Secondary	PSD of High Frequencies	Comparison of PSD of High Frequencies between RA patients with low fatigue and RA patients with high fatigue. PSD of High Frequencies is measured by VistaO2 device.	day 1
Secondary	normalized value of the High and Low frequencies	Comparison of normalized value of the High and Low frequencies between RA patients with low fatigue and RA patients with high fatigue. normalized value of the High and Low frequencies is measured by VistaO2 device.	day 1
Secondary	Physical activity	Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue. Physical activity is measured by IPAQ score.	day 1
Secondary	quality of sleep	Comparison of quality of sleep between RA patients with low fatigue and RA patients with high fatigue. Quality of sleep is measured by PSQI score.	day 1
Secondary	depression	Comparison of depression level between RA patients with low fatigue and RA patients with high fatigue. Depression is measured by HAD, BDI and HDRS scales.	day 1
Secondary	Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals	fatigue is measured with a visual analogic scale	day 1