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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Sponsored by
Centre Hospitalier Emile Roux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens Picardie - CETD
  • CH Ardèche Méridionale
  • CH Henri Mondor
  • CHU Jean Minjoz - CETD
  • HIA Clermont Tonnerre
  • CH Béziers
  • CHU Hôpital Côte de Nacre - CETD
  • CH Métropole Savoie
  • CH de Chartres
  • CHU Gabriel Montpied
  • CH du Pays de Craponne
  • CH de Dax
  • Centre Hospitalier de Dieppe
  • CH de Dreux
  • CHI Fréjus - Saint Raphaël
  • GMH
  • CHD Vendée
  • GH Littoral Atlantique
  • CHU Grenoble Alpes
  • CH Pierre Gallice
  • CH de Versailles
  • Centre Hospitalier du Mans
  • CH Emile Roux
  • CHU Dupuytren 2 - Centre de la douleur chronique
  • Clinique Mutualiste de la Porte de Lorient
  • Centre de la douleur Lille métropole
  • CHU Timone
  • Hôpital Sainte Blandine
  • CHI de Mont-de-Marsan
  • CH du Forez
  • GHR MSA - CETD - Site Muller
  • CHU Nord
  • CHR Orléans
  • GH Paris Saint Joseph
  • CH de Perpignan
  • CHU de Poitiers
  • CH René Dubos
  • CH Annecy Genevois
  • CH Saint-Nazaire
  • CHU de Saint-Etienne
  • Hôpital Pierre Paul Riquet - CHU Toulouse
  • CH de Valence
  • CH Jacques Lacarin
  • Hôpital Nord Ouest - Site Villefranche-sur-Saône
  • Médipôle Hôpital Mutualiste
  • CH Jacques Barrot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnosis orientation group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Assessing the pain severity of FMS
The pain severity of the FMS will be assessed using the WPI (widespread pain index) questionnaire, which represents the generalized pain index.
Assessing the symptom severity of FMS
The symptom severity of the FMS will be assessed using the SSS (symptom severity scale) questionnaire, which corresponds to the symptom severity scale.
Assessing the impact of the FMS on the patient's daily life
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.
Assessing the feeling of pain and the impact of pain on the patient's daily behavior
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.
Assess the patient's state of anxiety and depression
The patient's state of anxiety and depression will be assessed using the validated HADS - Hospital Anxiety and Depression Scale questionnaire.
Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)
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".
Describe the therapeutic measures (drug and non-drug) in place for the management of FMS
Therapeutics proposed for the management of symptoms associated with FMS will be identified (names of drug and non-drug treatments, care practices).
Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.
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.

Full Information

First Posted
February 23, 2021
Last Updated
April 28, 2023
Sponsor
Centre Hospitalier Emile Roux
Collaborators
Walisco, University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04775368
Brief Title
Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
Acronym
FIBOBS
Official Title
Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Emile Roux
Collaborators
Walisco, University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis orientation group
Arm Type
Experimental
Arm Description
For this study, there is only one arm. Each patient complete diagnosis questionnaires.
Intervention Type
Other
Intervention Name(s)
Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing the prevalence of sleep disorders in general in patients with FMS
Description
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.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS
Description
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.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS
Description
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.
Time Frame
Only once, by the patient within 14 days of inclusion.
Secondary Outcome Measure Information:
Title
Assessing the pain severity of FMS
Description
The pain severity of the FMS will be assessed using the WPI (widespread pain index) questionnaire, which represents the generalized pain index.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assessing the symptom severity of FMS
Description
The symptom severity of the FMS will be assessed using the SSS (symptom severity scale) questionnaire, which corresponds to the symptom severity scale.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assessing the impact of the FMS on the patient's daily life
Description
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.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assessing the feeling of pain and the impact of pain on the patient's daily behavior
Description
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.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Assess the patient's state of anxiety and depression
Description
The patient's state of anxiety and depression will be assessed using the validated HADS - Hospital Anxiety and Depression Scale questionnaire.
Time Frame
Only once, by the patient within 14 days of inclusion.
Title
Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)
Description
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".
Time Frame
Only once, by the pain physician at the inclusion.
Title
Describe the therapeutic measures (drug and non-drug) in place for the management of FMS
Description
Therapeutics proposed for the management of symptoms associated with FMS will be identified (names of drug and non-drug treatments, care practices).
Time Frame
Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.
Title
Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.
Description
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.
Time Frame
Throught study completion, an average of 4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert ANDRE, MD
Organizational Affiliation
CH Emile Roux - Le Puy-en-Velay
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie - CETD
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CH Ardèche Méridionale
City
Aubenas
ZIP/Postal Code
07200
Country
France
Facility Name
CH Henri Mondor
City
Aurillac
ZIP/Postal Code
15000
Country
France
Facility Name
CHU Jean Minjoz - CETD
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
HIA Clermont Tonnerre
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CH Béziers
City
Béziers
ZIP/Postal Code
34500
Country
France
Facility Name
CHU Hôpital Côte de Nacre - CETD
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CH Métropole Savoie
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
CH de Chartres
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CH du Pays de Craponne
City
Craponne-sur-Arzon
ZIP/Postal Code
43500
Country
France
Facility Name
CH de Dax
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
Centre Hospitalier de Dieppe
City
Dieppe
ZIP/Postal Code
76200
Country
France
Facility Name
CH de Dreux
City
Dreux
ZIP/Postal Code
28102
Country
France
Facility Name
CHI Fréjus - Saint Raphaël
City
Fréjus
ZIP/Postal Code
83608
Country
France
Facility Name
GMH
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
GH Littoral Atlantique
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CH Pierre Gallice
City
Langeac
ZIP/Postal Code
43300
Country
France
Facility Name
CH de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CH Emile Roux
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Facility Name
CHU Dupuytren 2 - Centre de la douleur chronique
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique Mutualiste de la Porte de Lorient
City
Lorient
ZIP/Postal Code
56324
Country
France
Facility Name
Centre de la douleur Lille métropole
City
Marquette-lez-Lille
ZIP/Postal Code
59520
Country
France
Facility Name
CHU Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Sainte Blandine
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
CHI de Mont-de-Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40024
Country
France
Facility Name
CH du Forez
City
Montbrison
ZIP/Postal Code
42600
Country
France
Facility Name
GHR MSA - CETD - Site Muller
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
CHU Nord
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
GH Paris Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CH de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CH René Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
CH Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Facility Name
CH Saint-Nazaire
City
Saint-Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital Pierre Paul Riquet - CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CH de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
CH Jacques Lacarin
City
Vichy
ZIP/Postal Code
03200
Country
France
Facility Name
Hôpital Nord Ouest - Site Villefranche-sur-Saône
City
Villefranche-sur-Saône
ZIP/Postal Code
69655
Country
France
Facility Name
Médipôle Hôpital Mutualiste
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
CH Jacques Barrot
City
Yssingeaux
ZIP/Postal Code
43200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36180114
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.
Results Reference
derived

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

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