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OpenTrials
Completed

NCT Number: NCT02475486

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Fatigue Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VistaO2

Device

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

Primary outcomes

  1. Ratio low/high frequencies of power spectral density of R-R intervals

    Time frame: day1

    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.

Secondary outcomes

  1. Number of sleep apnea syndrome

    Time frame: day 1

    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.

  2. Standard deviation of all R-R intervals (SDNN)

    Time frame: day 1

    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.

  3. Total Power spectral density (PSD)

    Time frame: day 1

    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.

  4. PSD of Lower Frequencies

    Time frame: day 1

    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.

  5. PSD of High Frequencies

    Time frame: day 1

    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.

  6. normalized value of the High and Low frequencies

    Time frame: day 1

    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.

  7. Physical activity

    Time frame: day 1

    Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue. Physical activity is measured by IPAQ score.

  8. quality of sleep

    Time frame: day 1

    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.

  9. depression

    Time frame: day 1

    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.

  10. Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals

    Time frame: day 1

    fatigue is measured with a visual analogic scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Acronym: ANSRA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2015
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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