Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders (NCT04775368) | Clinical Trial Compass
CompletedNot Applicable
Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
France601 participantsStarted 2021-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing the prevalence of sleep disorders in general in patients with FMS
Timeframe: Only once, by the patient within 14 days of inclusion.
2
Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS
Timeframe: Only once, by the patient within 14 days of inclusion.
3
Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS
Timeframe: Only once, by the patient within 14 days of inclusion.