Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil (FIBOBS)

  • End date
    Jan 14, 2024
  • participants needed
  • sponsor
    Centre Hospitalier Emile Roux
Updated on 23 October 2022
chronic pain


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.

Condition Fibromyalgia
Treatment Administering diagnostic orientation questionnaires for the screening of possible sleep disorders, Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Clinical Study IdentifierNCT04775368
SponsorCentre Hospitalier Emile Roux
Last Modified on23 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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