Clinical trial NCT04775368: Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
Official title: Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
Collaborators: name: Walisco
name: University Hospital, Clermont-Ferrand
First posted: 2021-03-01
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessing the prevalence of sleep disorders in general in patients with FMS
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: 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.
measure: 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.
Secondary outcomes:
measure: Assessing the pain severity of FMS
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: Assessing the symptom severity of FMS
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: Assessing the impact of the FMS on the patient's daily life
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: Assessing the feeling of pain and the impact of pain on the patient's daily behavior
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: Assess the patient's state of anxiety and depression
timeFrame: Only once, by the patient within 14 days of inclusion.
measure: Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)
timeFrame: Only once, by the pain physician at the inclusion.
measure: Describe the therapeutic measures (drug and non-drug) in place for the management of FMS
timeFrame: Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.
measure: Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.
timeFrame: Throught study completion, an average of 4 months.
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie - CETD
city: Aubenas
country: France
facility: CH Ardèche Méridionale
city: Aurillac
country: France
facility: CH Henri Mondor
city: Besançon
country: France
facility: CHU Jean Minjoz - CETD
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Béziers
country: France
facility: CH Béziers
city: Caen
country: France
facility: CHU Hôpital Côte de Nacre - CETD
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Chartres
country: France
facility: CH de Chartres
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Craponne-sur-Arzon
country: France
facility: CH du Pays de Craponne
city: Dax
country: France
facility: CH de Dax
city: Dieppe
country: France
facility: Centre Hospitalier de Dieppe
city: Dreux
country: France
facility: CH de Dreux
city: Fréjus
country: France
facility: CHI Fréjus - Saint Raphaël
city: Grenoble
country: France
facility: GMH
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: GH Littoral Atlantique
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Langeac
country: France
facility: CH Pierre Gallice
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Limoges
country: France
facility: CHU Dupuytren 2 - Centre de la douleur chronique
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de Lorient
city: Marquette-lez-Lille
country: France
facility: Centre de la douleur Lille métropole
city: Marseille
country: France
facility: CHU Timone
city: Metz
country: France
facility: Hôpital Sainte Blandine
city: Mont-de-Marsan
country: France
facility: CHI de Mont-de-Marsan
city: Montbrison
country: France
facility: CH du Forez
city: Mulhouse
country: France
facility: GHR MSA - CETD - Site Muller
city: Nantes
country: France
facility: CHU Nord
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: GH Paris Saint Joseph
city: Perpignan
country: France
facility: CH de Perpignan
city: Poitiers
country: France
facility: CHU de Poitiers
city: Pontoise
country: France
facility: CH René Dubos
city: Pringy
country: France
facility: CH Annecy Genevois
city: Saint-Nazaire
country: France
facility: CH Saint-Nazaire
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet - CHU Toulouse
city: Valence
country: France
facility: CH de Valence
city: Vichy
country: France
facility: CH Jacques Lacarin
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord Ouest - Site Villefranche-sur-Saône
city: Villeurbanne
country: France
facility: Médipôle Hôpital Mutualiste
city: Yssingeaux
country: France
facility: CH Jacques Barrot
Study officials:
affiliation: CH Emile Roux - Le Puy-en-Velay
name: Gilbert ANDRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andre G, Petitjean P, Haas V, Geraud E, Fantini ML, Creac'h C, Perez C, Bonnefoi M, Gadea E. Screening and management of sleep disorders in patients with fibromyalgia syndrome: a French multicentred, prospective, observational study protocol (FIBOBS). BMJ Open. 2022 Sep 30;12(9):e062549. doi: 10.1136/bmjopen-2022-062549.