Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders (FIBOBS)

Centre Hospitalier Emile Roux

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Administering diagnosis orientation questionnaires for the screening of possible sleep disorders

Study type

Interventional

Funder types

Other

Identifiers

NCT04775368

RIPH2_ANDRE_FIBOBS

2020-A02940-39 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

601 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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