NCT07057232 Chronic Insomnia in Non-Cancer Pain Patients
| NCT ID | NCT07057232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Germans Trias i Pujol Hospital |
| Condition | Chronic Non-cancer Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 385 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 385 participants in total. It began in 2025-06-09 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pain and sleep are closely linked physiological processes that support overall health and functioning. Increasing evidence shows a dynamic, bidirectional relationship: poor sleep increases pain sensitivity, while chronic pain disrupts normal sleep. Both conditions are highly prevalent and significantly impair quality of life, making them major public health concerns. Chronic pain, defined as pain lasting more than three months, affects around 17% of adults in Spain. Insomnia, though common, is harder to define due to its overlap with medical and psychiatric conditions. It may present as a symptom, a syndrome, or a formal sleep disorder, leading to variability in prevalence estimates. Current diagnostic criteria, including DSM-5 and the International Classification of Sleep Disorders, Third Edition (ICSD-3), adopt the unified concept of chronic insomnia disorder, defined as persistent difficulty with sleep initiation, maintenance, or quality, despite adequate opportunity for sleep, and associated with daytime impairment. ICSD-3 distinguishes three types of insomnia: * Chronic insomnia disorder: symptoms ≥3 times/week for ≥3 months; * Short-term insomnia disorder: symptoms lasting less than 3 months; * Other insomnia disorder: symptoms not meeting criteria for the above. About one-third of the general population reports insomnia symptoms. However, when both night symptoms and daytime impact are considered, the prevalence of chronic insomnia disorder is estimated at 6-10%. Women are more frequently affected, with a female-to-male ratio of about 1.4:1. Despite this, few studies have assessed insomnia specifically in people with chronic non-cancer pain. This gap is important, as untreated insomnia may worsen pain and reduce treatment efficacy, reinforcing a vicious cycle. This observational study (PainSomnia) aims to estimate the prevalence of chronic insomnia among adults with chronic non-cancer pain. The results will help support integrated, individualized treatment approaches that address both sleep and pain in this high-risk population.
Eligibility Criteria
Inclusion Criteria: * Aged 18 years or older * Either biological sex * Diagnosed with chronic non-cancer pain * Receiving care in a pain unit or by a pain specialist * Able to understand and participate in the study * Who sign informed consent Exclusion Criteria: * Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator
Contact & Investigator
Antonio Montes Pérez, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital del Mar
Frequently Asked Questions
Who can join the NCT07057232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Non-cancer Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07057232 currently recruiting?
Yes, NCT07057232 is actively recruiting participants. Contact the research team at amontes@psmar.cat for enrollment information.
Where is the NCT07057232 trial being conducted?
This trial is being conducted at Badalona, Spain, Barcelona, Spain, Barcelona, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT07057232 clinical trial?
NCT07057232 is sponsored by Germans Trias i Pujol Hospital. The principal investigator is Antonio Montes Pérez, MD, PhD at Hospital del Mar. The trial plans to enroll 385 participants.
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