Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 385
- 试验地点
- 15
- 主要终点
- Proportion of patients with chronic non-cancer pain and insomnia
研究概览
简要总结
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.
详细描述
Sleep and pain are two biologically and evolutionarily significant processes that play a fundamental role in maintaining health and protecting bodily function. These processes interact through a delicate physiological balance. Although the exact mechanisms underlying the relationship between pain and sleep are still under investigation, current evidence supports a dynamic and bidirectional interaction between the two. Pain can disrupt sleep and reduce its capacity to provide necessary physiological and mental recovery. Conversely, inadequate or fragmented sleep can worsen existing pain conditions or contribute to the development of new pain syndromes, further impairing sleep continuity and quality.
Due to their high prevalence and impact on health and daily functioning, chronic pain and insomnia represent two major public health challenges and are associated with substantial economic and social costs.
Chronic Pain Chronic pain is typically defined as pain that persists for longer than three months and is associated with significant emotional distress, functional impairment, or both. The Pain Proposal, a European initiative aimed at understanding the burden of chronic pain, estimated that approximately 19% of the European population is affected by chronic pain. In Spain, the estimated prevalence is slightly lower, at around 17%. The economic burden of chronic pain is considerable-estimated at over €300 billion annually across Europe, accounting for roughly 1.5% to 3% of GDP. In Spain, the national cost is estimated at €16 billion annually, or approximately 2.5% of GDP.
Chronic pain has a profound negative impact on patients' quality of life, affecting physical health, emotional well-being, and social, familial, and occupational functioning. Comorbidities are common. In Spain, approximately 47% of patients with chronic pain also experience depression, and 50% report sleep disturbances. Sleep disturbances in this context encompass a range of conditions, including difficulties with sleep initiation and maintenance, as well as abnormal events during sleep such as sleep apnea, restless legs syndrome, and insomnia.
Insomnia The diagnostic criteria for insomnia have undergone significant revisions in recent years. Both the DSM-5 and the ICSD-3 have simplified and unified the diagnostic categories, moving toward a more clinically relevant concept of chronic insomnia disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator
结局指标
主要结局
Proportion of patients with chronic non-cancer pain and insomnia
时间窗: At a single time point during the baseline visit.
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).
次要结局
- Proportion of patients with chronic non-cancer pain and moderate/severe pain intensity (>4).(At a single time point during the baseline visit.)
- Proportion of patients with moderate to severe chronic non-cancer pain intensity, and chronic insomnia.(At a single time point during the baseline visit.)
- Proportion of patients with poor sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)(At a single time point during the baseline visit)
- Proportion of patients with chronic non-cancer pain and clinically significant anxiety(At a single time point during the baseline visit)
- Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant anxiety(At a single time point during the baseline visit)
- Proportion of patients with chronic non-cancer pain and clinically significant depression.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain and positive mood.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant depression.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain, chronic insomnia, and positive mood.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain and reduced well-being or functional capacity.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain, chronic insomnia, and reduced well-being or functional capacity.(At a single time point during the baseline visit.)
- Proportion of patients with chronic non-cancer pain who use benzodiazepines or hypnotic medications.(At a single time point during the baseline visit.)