Improving care for chronic pain patients by including sleep specialists
Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil
This study is testing if adding sleep specialists to the care of people with chronic pain can help improve their pain management and sleep quality.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 664 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Emile Roux Academic / other |
| Locations | 1 site (Le Puy-en-Velay) |
| Trial ID | NCT06052384 on ClinicalTrials.gov |
What this trial studies
This interventional study, known as DOLOREPIT, evaluates two different care pathways for managing chronic pain by integrating sleep disorder management into standard pain management practices. It is a multicenter, randomized, controlled, open-label trial that aims to assess the effectiveness of this integrated approach. Patients will be monitored for their pain management outcomes and sleep quality over the course of the study. The goal is to determine if addressing sleep issues can enhance the overall care and quality of life for individuals suffering from chronic pain.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing chronic pain that has persisted for over three months and who have not responded adequately to previous treatments.
Not a fit: Patients with acute pain or those whose chronic pain is not associated with sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and quality of life for patients with chronic pain.
How similar studies have performed: While integrating sleep management into chronic pain treatment is a novel approach, similar studies have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First consultation at the pain management center * Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics: * Persistence or recurrence * Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months; * Inadequate response to treatment; * Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain. * Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories: * Chronic generalized pain * Complex regional pain syndrome * Chronic primary headache or orofacial pain * Chronic primary musculoskeletal pain * Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes) * Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected * Affiliation to a French social security system * Free informed consent Exclusion Criteria: * Patients undergoing cancer treatment or who have completed treatment within the last 2 years * Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.) * Immunocompromised patient * Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator) * Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion) * Patient follow-up difficult (for geographic motives or other reasons) * Patient under judicial protection of incapable adults or guardianship * Refusal to participate in the research
Where this trial is running
Le Puy-en-Velay
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.