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RECRUITING
NCT07057232

Chronic Insomnia in Non-Cancer Pain Patients

Sponsor: Germans Trias i Pujol Hospital

View on ClinicalTrials.gov

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.

Official title: Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

385

Start Date

2025-06-09

Completion Date

2025-12

Last Updated

2025-07-14

Healthy Volunteers

No

Interventions

OTHER

Usual care provided from pain specialist or within a dedicated pain unit

Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit

Locations (15)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, Spain

Instituto de Medicina y Cirugía

Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital del Mar

Barcelona, Catalonia, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, Spain

Hospital de Viladecans

Hospitalet Del Llobregat, Catalonia, Spain

Hospital Universitari de Bellvitge

Hospitalet Del Llobregat, Catalonia, Spain

Centre Avantmèdic Ponent

Lleida, Catalonia, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, Spain

Complex Hospitalari Moisés Broggi

Sant Joan Despí, Catalonia, Spain

Hospital Universitari Joan XXIII

Tarragona, Catalonia, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Catalonia, Spain

Hospital de Tortosa Verge de la Cinta

Tarragona, Catalonia, Spain

Consorci Sanitari de Terrassa

Terrassa, Catalonia, Spain