Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF (ANSRA)
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Saint-etienne、フランス、42055
- Chu Saint-Etienne
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の: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
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ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
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他の: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
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ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Ratio low/high frequencies of power spectral density of R-R intervals
時間枠:day1
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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.
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day1
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of sleep apnea syndrome
時間枠:day 1
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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.
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day 1
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Standard deviation of all R-R intervals (SDNN)
時間枠:day 1
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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.
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day 1
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Total Power spectral density (PSD)
時間枠:day 1
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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.
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day 1
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PSD of Lower Frequencies
時間枠:day 1
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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.
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day 1
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PSD of High Frequencies
時間枠:day 1
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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.
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day 1
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normalized value of the High and Low frequencies
時間枠:day 1
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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.
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day 1
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Physical activity
時間枠:day 1
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Comparison of physical activity between RA patients with low fatigue and RA patients with high fatigue.
Physical activity is measured by IPAQ score.
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day 1
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quality of sleep
時間枠:day 1
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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.
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day 1
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depression
時間枠:day 1
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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.
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day 1
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Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
時間枠:day 1
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fatigue is measured with a visual analogic scale
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day 1
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協力者と研究者
協力者
捜査官
- 主任研究者:Hubert Marotte, PUPH、Chu Saint-Etienne
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
VistaO2の臨床試験
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Centre Hospitalier Universitaire de Saint EtienneNovacor終了しました