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

NCT04775368 | Completed

• 2 other identifiers: RIPH2_ANDRE_FIBOBS2020-A02940-39
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 46

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• Assessing the prevalence of sleep disorders in general in patients with FMS

  The prevalence of sleep disorders will be estimated from the results of the Pittsburgh Sleep Quality Index Questionnaire (PSQI) which is a generic, validated 19-item self-administered questionnaire for measuring sleep problems.

  Only once, by the patient within 14 days of inclusion.

• Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS

  The prevalence of sleep disorders for the specific risk of sleep apnea syndrome will be estimated from the results of the STOP-BANG questionnaire. This questionnaire guide the diagnosis of sleep apnea syndrome and is composed of 8 items.

  Only once, by the patient within 14 days of inclusion.

• Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS

  The prevalence of sleep disorders will be estimated from the results of the simple question which is a rapid screening tool that provides a diagnosis of probable restless legs syndrome (RLS). Patients who answer positively to this question will complete the International Restless Legs Syndrome (IRLS) questionnaire which assesses the severity of restless legs syndrome on four levels: mild, moderate, severe and very severe.

  Only once, by the patient within 14 days of inclusion.

Secondary Outcomes (8)

• Assessing the pain severity of FMS

  Only once, by the patient within 14 days of inclusion.

• Assessing the symptom severity of FMS

  Only once, by the patient within 14 days of inclusion.

• Assessing the impact of the FMS on the patient's daily life

  Only once, by the patient within 14 days of inclusion.

• Assessing the feeling of pain and the impact of pain on the patient's daily behavior

  Only once, by the patient within 14 days of inclusion.

• Assess the patient's state of anxiety and depression

  Only once, by the patient within 14 days of inclusion.

Study Arms (1)

Diagnosis orientation group

EXPERIMENTAL

For this study, there is only one arm. Each patient complete diagnosis questionnaires.

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

Interventions

Administering diagnosis orientation questionnaires for the screening of possible sleep disorders OTHER

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.

Diagnosis orientation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead
• Walisco: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (46)

CHU Amiens Picardie - CETD

Amiens, 80054, France

Location

CH Ardèche Méridionale

Aubenas, 07200, France

Location

CH Henri Mondor

Aurillac, 15000, France

Location

CHU Jean Minjoz - CETD

Besançon, 25030, France

Location

CH Béziers

Béziers, 34500, France

Location

HIA Clermont Tonnerre

Brest, 29200, France

Location

CHU Hôpital Côte de Nacre - CETD

Caen, 14000, France

Location

CH Métropole Savoie

Chambéry, 73011, France

Location

CH de Chartres

Chartres, 28018, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CH du Pays de Craponne

Craponne-sur-Arzon, 43500, France

Location

CH de Dax

Dax, 40100, France

Location

Centre Hospitalier de Dieppe

Dieppe, 76200, France

Location

CH de Dreux

Dreux, 28102, France

Location

CHI Fréjus - Saint Raphaël

Fréjus, 83608, France

Location

GMH

Grenoble, 38000, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

GH Littoral Atlantique

La Rochelle, 17000, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

CH Pierre Gallice

Langeac, 43300, France

Location

CH de Versailles

Le Chesnay, 78150, France

Location

Centre Hospitalier du Mans

Le Mans, 72037, France

Location

CH Emile Roux

Le Puy-en-Velay, 43000, France

Location

CHU Dupuytren 2 - Centre de la douleur chronique

Limoges, 87042, France

Location

Clinique Mutualiste de la Porte de Lorient

Lorient, 56324, France

Location

Centre de la douleur Lille métropole

Marquette-lez-Lille, 59520, France

Location

CHU Timone

Marseille, 13005, France

Location

Hôpital Sainte Blandine

Metz, 57000, France

Location

CHI de Mont-de-Marsan

Mont-de-Marsan, 40024, France

Location

CH du Forez

Montbrison, 42600, France

Location

GHR MSA - CETD - Site Muller

Mulhouse, 68070, France

Location

CHU Nord

Nantes, 44093, France

Location

CHR Orléans

Orléans, 45067, France

Location

GH Paris Saint Joseph

Paris, 75674, France

Location

CH de Perpignan

Perpignan, 66046, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CH René Dubos

Pontoise, 95300, France

Location

CH Annecy Genevois

Pringy, 74374, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

CH Saint-Nazaire

Saint-Nazaire, 44606, France

Location

Hôpital Pierre Paul Riquet - CHU Toulouse

Toulouse, 31059, France

Location

CH de Valence

Valence, 26953, France

Location

CH Jacques Lacarin

Vichy, 03200, France

Location

Hôpital Nord Ouest - Site Villefranche-sur-Saône

Villefranche-sur-Saône, 69655, France

Location

Médipôle Hôpital Mutualiste

Villeurbanne, 69100, France

Location

CH Jacques Barrot

Yssingeaux, 43200, France

Location

Related Publications (1)

• 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.

  PMID: 36180114 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gilbert ANDRE, MD

  CH Emile Roux - Le Puy-en-Velay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: April 1, 2021
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (46)