Clinical trial · Observational
Chronic Insomnia in Non-Cancer Pain Patients
Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Non-cancer Pain | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Usual care provided from pain specialist or within a dedicated pain unit | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chronic non-cancer pain patients
- description
- Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.
- interventionNames
- Other: Usual care provided from pain specialist or within a dedicated pain unit
Primary outcomes (1)
- measure
- Proportion of patients with chronic non-cancer pain and insomnia
- timeFrame
- At a single time point during the baseline visit.
- description
- Chronic insomnia will be assessed based on participants' self-reports. A positive screening will require affirmative responses to all five diagnostic criteria (Criteria A-E) for insomnia disorder, as defined by the ICSD-3 Diagnostic Criteria for Insomnia Disorder, as well as confirmation that sleep initiation or maintenance difficulties occur more than three times per week and have persisted for at least three months. For participants reporting chronic insomnia, severity will be evaluated using the Insomnia Severity Index (ISI), a validated 7-item questionnaire with total scores ranging from 0 to 28. The global ISI score is interpreted as follows: 0-7: no clinically significant insomnia; 8-14: subthreshold insomnia; 15-21: clinical insomnia (moderate severity); 22-28: clinical insomnia (severe) (Bastien, 2001).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBuysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
- BACKGROUNDBastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. PMID 11438246