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Could hidden sleep problems be worsening fibromyalgia?

NCT ID NCT04775368

Knowledge-focused Sponsor: Centre Hospitalier Emile Roux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study looks at how often sleep disorders—like poor sleep quality, sleep apnea, and restless legs syndrome—occur in people with fibromyalgia. Researchers will use questionnaires to screen patients in specialized pain clinics across France. They will also ask doctors how they currently detect and manage sleep issues in these patients. The goal is to better understand the link between sleep and fibromyalgia symptoms, which could lead to improved care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diagnostic orientation questionnaires for sleep disorder screening
What this could lead to
If successful, this could lead to better detection and management of sleep problems in fibromyalgia, potentially improving patients' quality of life.
What could go wrong
This is an observational study, so it won't test a treatment. It may only reveal how common sleep issues are, not whether fixing them helps fibromyalgia symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

598 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • CH Annecy Genevois

    Pringy, 74374, France

  • CH Ardèche Méridionale

    Aubenas, 07200, France

  • CH Béziers

    Béziers, 34500, France

  • CH Emile Roux

    Le Puy-en-Velay, 43000, France

  • CH Henri Mondor

    Aurillac, 15000, France

  • CH Jacques Barrot

    Yssingeaux, 43200, France

  • CH Jacques Lacarin

    Vichy, 03200, France

  • CH Métropole Savoie

    Chambéry, 73011, France

  • CH Pierre Gallice

    Langeac, 43300, France

  • CH René Dubos

    Pontoise, 95300, France

  • CH Saint-Nazaire

    Saint-Nazaire, 44606, France

  • CH de Chartres

    Chartres, 28018, France

  • CH de Dax

    Dax, 40100, France

  • CH de Dreux

    Dreux, 28102, France

  • CH de Perpignan

    Perpignan, 66046, France

  • CH de Valence

    Valence, 26953, France

  • CH de Versailles

    Le Chesnay, 78150, France

  • CH du Forez

    Montbrison, 42600, France

  • CH du Pays de Craponne

    Craponne-sur-Arzon, 43500, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHI Fréjus - Saint Raphaël

    Fréjus, 83608, France

  • CHI de Mont-de-Marsan

    Mont-de-Marsan, 40024, France

  • CHR Orléans

    Orléans, 45067, France

  • CHU Amiens Picardie - CETD

    Amiens, 80054, France

  • CHU Dupuytren 2 - Centre de la douleur chronique

    Limoges, 87042, France

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU Grenoble Alpes

    La Tronche, 38700, France

  • CHU Hôpital Côte de Nacre - CETD

    Caen, 14000, France

  • CHU Jean Minjoz - CETD

    Besançon, 25030, France

  • CHU Nord

    Nantes, 44093, France

  • CHU Timone

    Marseille, 13005, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • CHU de Saint-Etienne

    Saint-Etienne, 42055, France

  • Centre Hospitalier de Dieppe

    Dieppe, 76200, France

  • Centre Hospitalier du Mans

    Le Mans, 72037, France

  • Centre de la douleur Lille métropole

    Marquette-lez-Lille, 59520, France

  • Clinique Mutualiste de la Porte de Lorient

    Lorient, 56324, France

  • GH Littoral Atlantique

    La Rochelle, 17000, France

  • GH Paris Saint Joseph

    Paris, 75674, France

  • GHR MSA - CETD - Site Muller

    Mulhouse, 68070, France

  • GMH

    Grenoble, 38000, France

  • HIA Clermont Tonnerre

    Brest, 29200, France

  • Hôpital Nord Ouest - Site Villefranche-sur-Saône

    Villefranche-sur-Saône, 69655, France

  • Hôpital Pierre Paul Riquet - CHU Toulouse

    Toulouse, 31059, France

  • Hôpital Sainte Blandine

    Metz, 57000, France

  • Médipôle Hôpital Mutualiste

    Villeurbanne, 69100, France

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