Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF (ANSRA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VistaO2
Sponsored by
About this trial
This is an interventional diagnostic trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, sympathetic nervous system, SNA, fatigue
Eligibility 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
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
high fatigue
low fatigue
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
fatigue is measured with a visual analogic scale
Full Information
NCT ID
NCT02475486
First Posted
June 16, 2015
Last Updated
June 25, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02475486
Brief Title
Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, sympathetic nervous system, SNA, fatigue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high fatigue
Arm Type
Other
Arm 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
Arm Title
low fatigue
Arm Type
Other
Arm 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
Intervention Type
Device
Intervention Name(s)
VistaO2
Intervention Description
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
Primary Outcome Measure Information:
Title
Ratio low/high frequencies of power spectral density of R-R intervals
Description
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.
Time Frame
day1
Secondary Outcome Measure Information:
Title
Number of sleep apnea syndrome
Description
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.
Time Frame
day 1
Title
Standard deviation of all R-R intervals (SDNN)
Description
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.
Time Frame
day 1
Title
Total Power spectral density (PSD)
Description
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.
Time Frame
day 1
Title
PSD of Lower Frequencies
Description
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.
Time Frame
day 1
Title
PSD of High Frequencies
Description
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.
Time Frame
day 1
Title
normalized value of the High and Low frequencies
Description
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.
Time Frame
day 1
Title
Physical activity
Description
Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue. Physical activity is measured by IPAQ score.
Time Frame
day 1
Title
quality of sleep
Description
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.
Time Frame
day 1
Title
depression
Description
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.
Time Frame
day 1
Title
Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
Description
fatigue is measured with a visual analogic scale
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Marotte, PUPH
Organizational Affiliation
CHU SAINT-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
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