Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
NCT ID: NCT04775368
Last Updated: 2023-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
601 participants
INTERVENTIONAL
2021-04-01
2023-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Diagnosis orientation group
For this study, there is only one arm. Each patient complete diagnosis questionnaires.
Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Several diagnosis orientation self-questionnaires will be conducted by the patient following his or her inclusion in order to detect, among other things, possible sleep disorders.
Interventions
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Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Several diagnosis orientation self-questionnaires will be conducted by the patient following his or her inclusion in order to detect, among other things, possible sleep disorders.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Walisco
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Centre Hospitalier Emile Roux
OTHER
Responsible Party
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Principal Investigators
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Gilbert ANDRE, MD
Role: PRINCIPAL_INVESTIGATOR
CH Emile Roux - Le Puy-en-Velay
Locations
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CHU Amiens Picardie - CETD
Amiens, , France
CH Ardèche Méridionale
Aubenas, , France
CH Henri Mondor
Aurillac, , France
CHU Jean Minjoz - CETD
Besançon, , France
CH Béziers
Béziers, , France
HIA Clermont Tonnerre
Brest, , France
CHU Hôpital Côte de Nacre - CETD
Caen, , France
CH Métropole Savoie
Chambéry, , France
CH de Chartres
Chartres, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
CH du Pays de Craponne
Craponne-sur-Arzon, , France
CH de Dax
Dax, , France
Centre Hospitalier de Dieppe
Dieppe, , France
CH de Dreux
Dreux, , France
CHI Fréjus - Saint Raphaël
Fréjus, , France
GMH
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
GH Littoral Atlantique
La Rochelle, , France
CHU Grenoble Alpes
La Tronche, , France
CH Pierre Gallice
Langeac, , France
CH de Versailles
Le Chesnay, , France
Centre Hospitalier du Mans
Le Mans, , France
CH Emile Roux
Le Puy-en-Velay, , France
CHU Dupuytren 2 - Centre de la douleur chronique
Limoges, , France
Clinique Mutualiste de la Porte de Lorient
Lorient, , France
Centre de la douleur Lille métropole
Marquette-lez-Lille, , France
CHU Timone
Marseille, , France
Hôpital Sainte Blandine
Metz, , France
CHI de Mont-de-Marsan
Mont-de-Marsan, , France
CH du Forez
Montbrison, , France
GHR MSA - CETD - Site Muller
Mulhouse, , France
CHU Nord
Nantes, , France
CHR Orléans
Orléans, , France
GH Paris Saint Joseph
Paris, , France
CH de Perpignan
Perpignan, , France
CHU de Poitiers
Poitiers, , France
CH René Dubos
Pontoise, , France
CH Annecy Genevois
Pringy, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CH Saint-Nazaire
Saint-Nazaire, , France
Hôpital Pierre Paul Riquet - CHU Toulouse
Toulouse, , France
CH de Valence
Valence, , France
CH Jacques Lacarin
Vichy, , France
Hôpital Nord Ouest - Site Villefranche-sur-Saône
Villefranche-sur-Saône, , France
Médipôle Hôpital Mutualiste
Villeurbanne, , France
CH Jacques Barrot
Yssingeaux, , France
Countries
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References
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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.
Other Identifiers
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2020-A02940-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
RIPH2_ANDRE_FIBOBS
Identifier Type: -
Identifier Source: org_study_id
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