跳至主要内容
临床试验/NCT07086599
NCT07086599招募中不适用

Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Type of sleep disorders

研究概览

简要总结

Chronic inflammatory rheumatisms (CIR) are a source of motor disability and various comorbidities, particularly cardiovascular and metabolic. They also significantly impact patients' quality of life, including sleep disturbances. Among CIRs, psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis, typically seronegative for rheumatoid factor. This heterogeneous disease affects peripheral and/or axial joints and can include extra-articular manifestations such as uveitis and chronic inflammatory bowel diseases. Its prevalence is estimated between 0.3% and 1% in the general population.

SAPHO syndrome, similar to psoriatic arthritis, is characterized by specific bone involvement with a hypertrophic tendency, often affecting the axial skeleton and the anterior thoracic wall. Pain and inflammation are closely linked to sleep quality, creating a vicious cycle where pain disrupts sleep and poor sleep amplifies pain perception. Analgesic treatments, such as opioids, can also cause nocturnal respiratory pathologies, further disrupting sleep.

Inflammatory processes are regulated by sleep, influencing plasma concentrations of CRP, IL6, and TNF production. Patients with psoriatic arthritis or SAPHO syndrome share common risk factors with Obstructive Sleep Apnea Syndrome (OSAS), such as obesity, hypertension, and metabolic syndrome.

Sleep disorders are common in the general population and likely underdiagnosed in these patients. Several studies suggest a link between sleep disorders and these rheumatic conditions, affecting quality of life and exacerbating symptoms. Questionnaires like the Epworth and Pichot scales provide a more precise evaluation of these symptoms. However, objective sleep exploration through polysomnography has never been conducted in these patients.

In summary, CIRs, particularly psoriatic arthritis and SAPHO syndrome, significantly impact patients' quality of life and sleep, necessitating appropriate evaluation and management of associated sleep disorders.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 years or older
  • Patient diagnosed with psoriatic arthritis or SAPHO syndrome and followed at Paris Saint-Joseph Hospital
  • Patient presenting sleep disorders warranting hospitalization for further -investigation of these disorders
  • French-speaking patient
  • Patient who does not oppose participation in the research protocol

排除标准

  • Patient already followed for a sleep disorder
  • Patient who underwent polysomnography in the last 2 years
  • End-of-life patient
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection

结局指标

主要结局

Type of sleep disorders

时间窗: at 6months

sleep disorders will be defined after polysomnography exam.

次要结局

  • evaluation of anxiety(at enrollement)
  • sleep structure(at 6 months)
  • presence and severity of asthenia,(at enrollement)
  • drowsiness evaluation(at enrollement)
  • Evaluation of Sleep Apnea(at enrollement, at 6months and at 12 months)
  • Sleep apnea severy(at enrollemnt, 6months and 12 months after)
  • Rheumatism disease activity(at enrollement, after 6 months and after 12 months)
  • CRP mesurement(at enrollment, 6months and 12 months after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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