Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 598
- 试验地点
- 46
- 主要终点
- Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS
研究概览
简要总结
The FIBOBS study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (CPS) in France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome (FMS) consulting within a CPS. The interaction between these sleep disorders and other symptoms of FMS will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with FMS are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of FMS. In addition, this study will provide a better understanding of the symptoms of FMS, their impact and how patients feel.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 筛查
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age ≥ 18 years old
- Read, write and understand the French language
- Patient with a diagnosis of Fibromyalgia Syndrome according to ACR 2010 criteria: Painful symptoms present at the same intensity for at least 3 months, WPI ≥ 7 and SSS ≥ 5 OR 3 ≤ WPI ≤ 6 and SSS ≥ 9, Any other cause responsible for chronic osteoarticular pain must be excluded.Primary or secondary fibromyalgia is eligible, at the discretion of the investigator.
- Patient seen in consultation for the first time or for a follow-up visit if the patient has already been followed up in the specialized chronic pain structure for less than a year.
- Have access to an internet connection (for the realization of the "patient questionnaire")
- Patient affiliated to a social security system
- Written and signed informed consent
排除标准
- Patient undergoing anti-cancer treatment or having completed treatment less than 2 years ago
- Patient under guardianship, deprived of liberty, safeguard of justice
- Pregnant or breastfeeding women
- Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
- Refusal to participate in research
研究组 & 干预措施
Diagnosis orientation group
For this study, there is only one arm. Each patient complete diagnosis questionnaires.
干预措施: Administering diagnosis orientation questionnaires for the screening of possible sleep disorders (Other)
结局指标
主要结局
Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS
时间窗: Only once, by the patient within 14 days of inclusion.
The prevalence of sleep disorders for the specific risk of sleep apnea syndrome will be estimated from the results of the STOP-BANG questionnaire. This questionnaire guide the diagnosis of sleep apnea syndrome and is composed of 8 items.
Assessing the prevalence of sleep disorders in general in patients with FMS
时间窗: Only once, by the patient within 14 days of inclusion.
The prevalence of sleep disorders will be estimated from the results of the Pittsburgh Sleep Quality Index Questionnaire (PSQI) which is a generic, validated 19-item self-administered questionnaire for measuring sleep problems.
Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS
时间窗: Only once, by the patient within 14 days of inclusion.
The prevalence of sleep disorders will be estimated from the results of the simple question which is a rapid screening tool that provides a diagnosis of probable restless legs syndrome (RLS). Patients who answer positively to this question will complete the International Restless Legs Syndrome (IRLS) questionnaire which assesses the severity of restless legs syndrome on four levels: mild, moderate, severe and very severe.
次要结局
- Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)(Only once, by the pain physician at the inclusion.)
- Describe the therapeutic measures (drug and non-drug) in place for the management of FMS(Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.)
- Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.(Throught study completion, an average of 4 months.)
- Assessing the symptom severity of FMS(Only once, by the patient within 14 days of inclusion.)
- Assessing the impact of the FMS on the patient's daily life(Only once, by the patient within 14 days of inclusion.)
- Assessing the feeling of pain and the impact of pain on the patient's daily behavior(Only once, by the patient within 14 days of inclusion.)
- Assess the patient's state of anxiety and depression(Only once, by the patient within 14 days of inclusion.)
- Assessing the pain severity of FMS(Only once, by the patient within 14 days of inclusion.)
研究者
研究点 (46)
标识符
- NCT 编号
- NCT04775368
- 其他研究编号
- RIPH2_ANDRE_FIBOBS, 2020-A02940-39
日期
- 首次提交
- (5年前)
- 首次发布
- (5年前)
- 主要完成日期
- (3年前)
- 研究完成日期
- (3年前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否