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Chronic Insomnia in Non-Cancer Pain Patients

RecruitingNCT07057232
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 ap…

Study details

Official title
Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain
Conditions
Interventions
  • Other: Usual care provided from pain specialist or within a dedicated pain unit
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Societat Catalana de Dolor (Catalan Society for Pain); Hospital del Mar
Start date
2025-06-09
Primary completion
2025-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Spain
Total sites listed
15

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07057232