Rheumatoid ArthritisANSRANCT02475486
Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
A study testing VistaO2 in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- VistaO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2016to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA diagnosis according to ACR/EULAR 2010
- RA with low disease activity according to DAS28 < 3.2
- Written consent obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- VistaO2
- Keywords
- Rheumatoid Arthritis, sympathetic nervous system, SNA, fatigue
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VistaO2Device
ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
| Study group | Role | What they receive |
|---|---|---|
| high fatigue | Other | 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 Receives: Device: VistaO2 |
| low fatigue | Other | 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 Receives: Device: VistaO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day1
Secondary outcomes (10)
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
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.
Measured: day 1
Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
fatigue is measured with a visual analogic scale
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start25 Feb 2016
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Hubert Marotte, PUPH, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475486
- Sponsor's protocol ID
- 1508054
- Other IDs
- 2015-A00655-44
- Acronym
- ANSRA
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2015
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475486
- Acronym / sponsor ID
- ANSRA / 1508054
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, sympathetic nervous system, SNA, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high fatigue | Other | Device: VistaO2Measure 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 |
| low fatigue | Other | Device: VistaO2Measure 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 |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RA diagnosis according to ACR/EULAR 2010
- RA with low disease activity according to DAS28 < 3.2
- Written consent obtained
Key exclusion criteria (6 listed)
- Other diagnosis than RA
- Depression known
- Hypertension treated or not,
- Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy,
- Pregnant or breastfeeding women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VistaO2ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients | Device | high fatigue, low fatigue |
Primary outcome
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.
10 secondary outcomes
Number of sleep apnea syndrome
Time frame: day 1
Standard deviation of all R-R intervals (SDNN)
Time frame: day 1
Total Power spectral density (PSD)
Time frame: day 1
PSD of Lower Frequencies
Time frame: day 1
PSD of High Frequencies
Time frame: day 1
normalized value of the High and Low frequencies
Time frame: day 1
Physical activity
Time frame: day 1
quality of sleep
Time frame: day 1
depression
Time frame: day 1
Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Marotte, PUPH principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VistaO2 in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio low/high frequencies of power spectral density of R-R intervals (time frame: day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.