Chronic Insomnia in Non-Cancer Pain Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGermans Trias i Pujol Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator
Trial population
Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Usual care provided from pain specialist or within a dedicated pain unit
Other interventionAdult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit
Treatment groups
385 Participants
are divided into 1 treatment groupGroup A: Chronic non-cancer pain patients1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with chronic non-cancer pain and insomnia
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).
Time frame
At a single time point during the baseline visit.Secondary outcomes
1
Proportion of patients with chronic non-cancer pain and moderate/severe pain intensity (>4).
Pain intensity will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 represents the worst pain imaginable. Moderate to severe pain is defined as a score greater than 4, based on the patient's reported worst pain during the past week.
Time frame
At a single time point during the baseline visit.2
Proportion of patients with moderate to severe chronic non-cancer pain intensity, and chronic insomnia.
This outcome combines pain and sleep criteria. Patients must meet both the chronic insomnia criteria (ICSD-3 + ISI) and report a pain score \>4 on the NRS to be included.
Time frame
At a single time point during the baseline visit.3
Proportion of patients with poor sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-reported questionnaire that assesses sleep disturbances over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The global score ranges from 0 to 21. A global score greater than 5 will be used to identify patients with poor sleep quality, based on established sensitivity (89.6%) and specificity (86.5%) thresholds (Buysse et al., 1989).
Time frame
At a single time point during the baseline visit4
Proportion of patients with chronic non-cancer pain and clinically significant anxiety
Anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS), a validated 14-item self-administered questionnaire. Seven items measure anxiety, with scores ranging from 0 to 21. A score of 11 or higher indicates clinically significant anxiety.
Time frame
At a single time point during the baseline visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Germans Trias i Pujol Hospital
Lead sponsor
Societat Catalana de Dolor (Catalan Society for Pain)
Collaborator
Hospital del Mar
Collaborator
Source ClinicalTrials.gov