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

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ClinicalTrials.gov Identifier: NCT02475486
Recruitment Status : Recruiting
First Posted : June 18, 2015
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: VistaO2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
high fatigue
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
Device: VistaO2
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475486


Contacts
Contact: Hubert MAROTE, PUPH (0)477127643 ext +33 hubert.marotte@chu-st-etienne.fr

Locations
France
Chu Saint-Etienne Recruiting
Saint-etienne, France, 42055
Contact: Hubert Marotte, PUPH    (0)477127643 ext +33    hubert.marotte@chu-st-etienne.fr   
Principal Investigator: Hubert Marotte, PUPH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Pfizer
Investigators
Principal Investigator: Hubert Marotte, PUPH CHU SAINT-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02475486     History of Changes
Other Study ID Numbers: 1508054
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Rheumatoid Arthritis
sympathetic nervous system
SNA
fatigue

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Fatigue
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms