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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 : Completed
First Posted : June 18, 2015
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE June 18, 2015
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE February 25, 2016
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Device: VistaO2
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
Study Arms  ICMJE
  • 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
    Intervention: Device: VistaO2
  • 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
    Intervention: Device: VistaO2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
100
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02475486
Other Study ID Numbers  ICMJE 1508054
2015-A00655-44 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Hubert Marotte, PUPH CHU SAINT-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP