An interventional study of Administering diagnosis orientation questionnaires for the screening of possible sleep disorders in Fibromyalgia, sponsored by Centre Hospitalier Emile Roux. Completed at 46 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Centre Hospitalier Emile Roux · Not applicable, Interventional, and Screening
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 598 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Centre Hospitalier Emile Roux is the lead sponsor of 20 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Only once, by the patient within 14 days of inclusion.
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.
Time frame: 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.
Time frame: 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.
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
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.
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.
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)
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.
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).
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.
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.
Plan to share: No
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Centre Hospitalier Emile Roux