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

April 28, 2023 updated by: Centre Hospitalier Emile Roux

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
601

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie - CETD
      • Aubenas, France, 07200
        • CH Ardèche Méridionale
      • Aurillac, France, 15000
        • CH Henri Mondor
      • Besançon, France, 25030
        • CHU Jean Minjoz - CETD
      • Brest, France, 29200
        • HIA Clermont Tonnerre
      • Béziers, France, 34500
        • Ch Beziers
      • Caen, France, 14000
        • CHU Hôpital Côte de Nacre - CETD
      • Chambéry, France, 73011
        • CH Métropole Savoie
      • Chartres, France, 28018
        • Ch de Chartres
      • Clermont-Ferrand, France, 63000
        • Chu Gabriel Montpied
      • Craponne-sur-Arzon, France, 43500
        • CH du Pays de Craponne
      • Dax, France, 40100
        • CH de Dax
      • Dieppe, France, 76200
        • Centre Hospitalier de Dieppe
      • Dreux, France, 28102
        • CH de Dreux
      • Fréjus, France, 83608
        • Chi Frejus - Saint Raphael
      • Grenoble, France, 38000
        • GMH
      • La Roche-sur-Yon, France, 85925
        • CHD Vendée
      • La Rochelle, France, 17000
        • GH Littoral Atlantique
      • La Tronche, France, 38700
        • CHU Grenoble Alpes
      • Langeac, France, 43300
        • CH Pierre Gallice
      • Le Chesnay, France, 78150
        • CH de Versailles
      • Le Mans, France, 72037
        • Centre Hospitalier du Mans
      • Le Puy-en-Velay, France, 43000
        • CH Emile Roux
      • Limoges, France, 87042
        • CHU Dupuytren 2 - Centre de la douleur chronique
      • Lorient, France, 56324
        • Clinique Mutualiste de la Porte de Lorient
      • Marquette-lez-Lille, France, 59520
        • Centre de la douleur Lille métropole
      • Marseille, France, 13005
        • CHU Timone
      • Metz, France, 57000
        • Hôpital Sainte Blandine
      • Mont-de-Marsan, France, 40024
        • CHI de Mont-de-Marsan
      • Montbrison, France, 42600
        • CH du Forez
      • Mulhouse, France, 68070
        • GHR MSA - CETD - Site Muller
      • Nantes, France, 44093
        • CHU Nord
      • Orléans, France, 45067
        • CHR Orléans
      • Paris, France, 75674
        • GH Paris Saint Joseph
      • Perpignan, France, 66046
        • CH de Perpignan
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Pontoise, France, 95300
        • CH René Dubos
      • Pringy, France, 74374
        • CH Annecy Genevois
      • Saint-Nazaire, France, 44606
        • CH Saint-Nazaire
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne
      • Toulouse, France, 31059
        • Hôpital Pierre Paul Riquet - CHU Toulouse
      • Valence, France, 26953
        • CH de Valence
      • Vichy, France, 03200
        • CH Jacques Lacarin
      • Villefranche-sur-Saône, France, 69655
        • Hôpital Nord Ouest - Site Villefranche-sur-Saône
      • Villeurbanne, France, 69100
        • Medipole Hopital Mutualiste
      • Yssingeaux, France, 43200
        • CH Jacques Barrot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diagnosis orientation group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessing the prevalence of sleep disorders in general in patients with FMS
Time Frame: Only once, by the patient within 14 days of inclusion.
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
Time Frame: Only once, by the patient within 14 days of inclusion.
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
Time Frame: Only once, by the patient within 14 days of inclusion.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing the pain severity of FMS
Time Frame: Only once, by the patient within 14 days of inclusion.
The pain severity of the FMS will be assessed using the WPI (widespread pain index) questionnaire, which represents the generalized pain index.
Only once, by the patient within 14 days of inclusion.
Assessing the symptom severity of FMS
Time Frame: Only once, by the patient within 14 days of inclusion.
The symptom severity of the FMS will be assessed using the SSS (symptom severity scale) questionnaire, which corresponds to the symptom severity scale.
Only once, by the patient within 14 days of inclusion.
Assessing the impact of the FMS on the patient's daily life
Time Frame: Only once, by the patient within 14 days of inclusion.
The impact of the FMS on the patient's daily life will be assessed by the QIF (French version of the Fibromyalgia Impact Questionnaire (FIQ)). This validated and commonly used questionnaire makes it possible to evaluate the functional incapacity and the repercussions of the FMS on daily life by evaluating the major symptoms: pain, fatigue, sleep disorders but also morning stiffness, anxiety and depression.
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
Time Frame: Only once, by the patient within 14 days of inclusion.
The painful feeling and the impact of pain on the patient's daily behavior will be assessed by the Concise Pain Questionnaire (QCD), the French version of the Brief Pain Inventory (BPI). This validated questionnaire makes it possible to assess the impact of pain on seven general aspects of the patient's life.
Only once, by the patient within 14 days of inclusion.
Assess the patient's state of anxiety and depression
Time Frame: Only once, by the patient within 14 days of inclusion.
The patient's state of anxiety and depression will be assessed using the validated HADS - Hospital Anxiety and Depression Scale questionnaire.
Only once, by the patient within 14 days of inclusion.
Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)
Time Frame: Only once, by the pain physician at the inclusion.
The assessment tools used by the pain physician to evaluate patients' pain, asthenia, sleep disorders and memory problems will be recorded in the "physician questionnaire".
Only once, by the pain physician at the inclusion.
Describe the therapeutic measures (drug and non-drug) in place for the management of FMS
Time Frame: Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.
Therapeutics proposed for the management of symptoms associated with FMS will be identified (names of drug and non-drug treatments, care practices).
Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.
Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.
Time Frame: Throught study completion, an average of 4 months.
The "patient questionnaire" will identify patients already diagnosed and treated for a sleep disorder. This will allow comparison with the prevalence calculated from the three screening questionnaires.
Throught study completion, an average of 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Emile Roux

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Clermont-Ferrand
Walisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilbert ANDRE, MD, CH Emile Roux - Le Puy-en-Velay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIPH2_ANDRE_FIBOBS
  • 2020-A02940-39 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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