FibromyalgiaFIBOBSNCT04775368
Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
A study testing Administering diagnosis orientation questionnaires for the screening of possible sleep disorders in people with Fibromyalgia, run by Centre Hospitalier Emile Roux at 46 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 46 sitesFrance
- Study dates
- 1 Apr 2021to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
France46 sites
CHU Amiens Picardie - CETD
Amiens, 80054
CH Ardèche Méridionale
Aubenas, 07200
CH Henri Mondor
Aurillac, 15000
CHU Jean Minjoz - CETD
Besançon, 25030
CH Béziers
Béziers, 34500
HIA Clermont Tonnerre
Brest, 29200
CHU Hôpital Côte de Nacre - CETD
Caen, 14000
CH Métropole Savoie
Chambéry, 73011
CH de Chartres
Chartres, 28018
CHU Gabriel Montpied
Clermont-Ferrand, 63000
CH du Pays de Craponne
Craponne-sur-Arzon, 43500
CH de Dax
Dax, 40100
Centre Hospitalier de Dieppe
Dieppe, 76200
CH de Dreux
Dreux, 28102
CHI Fréjus - Saint Raphaël
Fréjus, 83608
GMH
Grenoble, 38000
CHD Vendée
La Roche-sur-Yon, 85925
GH Littoral Atlantique
La Rochelle, 17000
CHU Grenoble Alpes
La Tronche, 38700
CH Pierre Gallice
Langeac, 43300
CH de Versailles
Le Chesnay, 78150
Centre Hospitalier du Mans
Le Mans, 72037
CH Emile Roux
Le Puy-en-Velay, 43000
CHU Dupuytren 2 - Centre de la douleur chronique
Limoges, 87042
Clinique Mutualiste de la Porte de Lorient
Lorient, 56324
Centre de la douleur Lille métropole
Marquette-lez-Lille, 59520
CHU Timone
Marseille, 13005
Hôpital Sainte Blandine
Metz, 57000
CHI de Mont-de-Marsan
Mont-de-Marsan, 40024
CH du Forez
Montbrison, 42600
GHR MSA - CETD - Site Muller
Mulhouse, 68070
CHU Nord
Nantes, 44093
CHR Orléans
Orléans, 45067
GH Paris Saint Joseph
Paris, 75674
CH de Perpignan
Perpignan, 66046
CHU de Poitiers
Poitiers, 86021
CH René Dubos
Pontoise, 95300
CH Annecy Genevois
Pringy, 74374
CHU de Saint-Etienne
Saint-Etienne, 42055
CH Saint-Nazaire
Saint-Nazaire, 44606
Hôpital Pierre Paul Riquet - CHU Toulouse
Toulouse, 31059
CH de Valence
Valence, 26953
CH Jacques Lacarin
Vichy, 03200
Hôpital Nord Ouest - Site Villefranche-sur-Saône
Villefranche-sur-Saône, 69655
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
CH Jacques Barrot
Yssingeaux, 43200
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering diagnosis orientation questionnaires for the screening of possible sleep disordersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis orientation group | Experimental | For this study, there is only one arm. Each patient complete diagnosis questionnaires. Receives: Other: Administering diagnosis orientation questionnaires for the screening of possible sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Only once, by the patient within 14 days of inclusion.
Secondary outcomes (8)
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.
Measured: Only once, by the patient within 14 days of inclusion.
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.
Measured: Only once, by the patient within 14 days of inclusion.
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.
Measured: 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
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.
Measured: Only once, by the patient within 14 days of inclusion.
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.
Measured: 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)
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".
Measured: Only once, by the pain physician at the inclusion.
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).
Measured: 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.
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.
Measured: Throught study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Collaborators
- Walisco, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Gilbert ANDRE, MD, Principal investigator, CH Emile Roux - Le Puy-en-Velay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775368
- Sponsor's protocol ID
- RIPH2_ANDRE_FIBOBS
- Other IDs
- 2020-A02940-39
- Acronym
- FIBOBS
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36180114Andre G, Bonnefoi M, Ramos I, Perez C, Luneau E, Gadea E. Screening and Management of Sleep Disorders in Patients with Fibromyalgia Syndrome: A French Multicenter, Prospective, Observational Study. Pain Ther. 2026 Apr;15(2):495-511. doi: 10.1007/s40122-025-00813-8. Epub 2026 Feb 1.
PubMed 41621042
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil
- ClinicalTrials.gov ID
- NCT04775368
- Acronym / sponsor ID
- FIBOBS / RIPH2_ANDRE_FIBOBS
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Collaborators
- Walisco, University Hospital, Clermont-Ferrand
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis orientation group | Experimental | Other: Administering diagnosis orientation questionnaires for the screening of possible sleep disordersFor this study, there is only one arm. Each patient complete diagnosis questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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")
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administering diagnosis orientation questionnaires for the screening of possible sleep disordersSeveral 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. | Other | Diagnosis orientation group |
Primary outcome
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.
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.
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.
8 secondary outcomes
Assessing the pain severity of FMS
Time frame: 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.
Assessing the impact of the FMS on the patient's daily life
Time frame: 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.
Assess the patient's state of anxiety and depression
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 36180114Andre 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 publication: PubMed 41621042Andre G, Bonnefoi M, Ramos I, Perez C, Luneau E, Gadea E. Screening and Management of Sleep Disorders in Patients with Fibromyalgia Syndrome: A French Multicenter, Prospective, Observational Study. Pain Ther. 2026 Apr;15(2):495-511. doi: 10.1007/s40122-025-00813-8. Epub 2026 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert ANDRE, MD principal investigator
CH Emile Roux - Le Puy-en-Velay
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administering diagnosis orientation questionnaires for the screening of possible sleep disorders in people with Fibromyalgia, run by Centre Hospitalier Emile Roux at 46 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775368, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.