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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitari Germans Trias i Pujol
ACTIVE_NOT_RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital del Mar
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Instituto de Medicina y Cirugía
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari de Girona Doctor Josep Trueta
ACTIVE_NOT_RECRUITING
Girona
Hospital de Viladecans
ACTIVE_NOT_RECRUITING
Hospitalet Del Llobregat
Hospital Universitari de Bellvitge
ACTIVE_NOT_RECRUITING
Hospitalet Del Llobregat
Centre Avantmèdic Ponent
RECRUITING
Lleida
Hospital Universitari Arnau de Vilanova
ACTIVE_NOT_RECRUITING
Lleida
Complex Hospitalari Moisés Broggi
ACTIVE_NOT_RECRUITING
Sant Joan Despí
Hospital de Tortosa Verge de la Cinta
ACTIVE_NOT_RECRUITING
Tarragona
Hospital Universitari Joan XXIII
ACTIVE_NOT_RECRUITING
Tarragona
Hospital Universitari Sant Joan de Reus
ACTIVE_NOT_RECRUITING
Tarragona
Consorci Sanitari de Terrassa
ACTIVE_NOT_RECRUITING
Terrassa
Contact Information
Primary
Antonio Montes Pérez, MD, PhD
amontes@psmar.cat
+34 932 48 30 00
Backup
Sebastián Videla Cés, MD, PhD
svidelac.germanstrias@gencat.cat
+34 934 65 12 00
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 385
Treatments
Chronic non-cancer pain patients
Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.
Related Therapeutic Areas
Sponsors
Collaborators: Societat Catalana de Dolor (Catalan Society for Pain), Hospital del Mar
Leads: Germans Trias i Pujol Hospital

This content was sourced from clinicaltrials.gov