Chronic Non-cancer PainPainSomniaNCT07057232
Chronic Insomnia in Non-Cancer Pain Patients
An observational study of Chronic Non-cancer Pain and Insomnia, run by Germans Trias i Pujol Hospital at 15 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-cancer Pain, Insomnia
- How many people
- 385 participants
- Where
- 15 sitesSpain
- Study dates
- 9 Jun 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.
Who may be able to join
- 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
Who cannot join
- Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Spain15 sites, 1 recruiting
- Active, not recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916
- Active, not recruiting
Instituto de Medicina y Cirugía
Barcelona, Catalonia, 08022
- Active, not recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
- Active, not recruiting
Hospital del Mar
Barcelona, Catalonia, 08916
- Active, not recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, 17007
- Active, not recruiting
Hospital de Viladecans
Hospitalet Del Llobregat, Catalonia, 08840
- Active, not recruiting
Hospital Universitari de Bellvitge
Hospitalet Del Llobregat, Catalonia, 08907
- Recruiting
Centre Avantmèdic Ponent
Lleida, Catalonia, 25008
Mercè Matute, MD, PhD, 973 72 80 90, mmatute@comll.cat
- Active, not recruiting
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198
- Active, not recruiting
Complex Hospitalari Moisés Broggi
Sant Joan Despí, Catalonia, 08970
- Active, not recruiting
Hospital Universitari Joan XXIII
Tarragona, Catalonia, 43005
- Active, not recruiting
Hospital Universitari Sant Joan de Reus
Tarragona, Catalonia, 43204
- Active, not recruiting
Hospital de Tortosa Verge de la Cinta
Tarragona, Catalonia, 43500
- Active, not recruiting
Consorci Sanitari de Terrassa
Terrassa, Catalonia, 08227
About this study
Official title: Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain
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.
Read more
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.
Read the detailed description
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.
According to ICSD-3, chronic insomnia is characterized by persistent difficulties in initiating or maintaining sleep, or experiencing restorative sleep, occurring at least three times per week for at least three months, despite adequate sleep opportunity and conditions. These disturbances must cause clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning. The thresholds used to define clinical significance-such as sleep onset latency or wakefulness after sleep onset greater than 20 minutes in youth or 30 minutes in older adults-are generally based on subjective reports and clinical observation.
Chronic Pain and Insomnia: A Bidirectional Relationship Historically, insomnia was viewed as a secondary consequence of chronic pain. However, more recent research highlights a bidirectional relationship, where each condition may contribute to and exacerbate the other. Pain can fragment sleep, while disrupted sleep reduces pain thresholds and can trigger spontaneous pain episodes.
Insomnia may act as both a trigger and a perpetuating factor in chronic pain. A landmark sleep deprivation study conducted in 1999 at the University of Washington found that women subjected to selective sleep deprivation exhibited decreased pain tolerance. Since then, multiple studies have confirmed that individuals with insomnia exhibit heightened sensitivity to experimental pain stimuli.
There is strong evidence that short or disrupted sleep can induce hyperalgesia. Additionally, chronic sleep loss has been shown to predict the onset or worsening of chronic pain conditions. Longitudinal studies further support the idea that sleep problems in individuals without existing pain may significantly increase the risk of developing chronic pain syndromes.
The central nervous system has built-in mechanisms to preserve sleep, including neural filtering at the brainstem and descending inhibitory pathways designed to suppress the arousing effects of incoming sensory information. However, pain can override these mechanisms, disrupting both the continuity and architecture of sleep. The extent of this disruption depends on both the intensity of nociceptive stimuli and the individual's susceptibility to sleep fragmentation.
Clinical Relevance and Research Gap Patients with chronic pain are at significantly higher risk for insomnia compared to individuals without pain. The interaction between chronic pain and chronic insomnia is best understood as a vicious cycle in which each condition amplifies the other.
Current clinical guidelines advocate for a multidisciplinary approach to managing chronic pain, which includes addressing associated conditions such as insomnia. Failing to treat insomnia in this population can create a major barrier to effective pain management.
Despite the high co-occurrence of these conditions, no studies to date have quantified the prevalence of chronic insomnia among patients with chronic non-cancer pain in the Spanish population. Although prior studies have estimated the prevalence of sleep disturbances in chronic pain populations to range from 50% to 90%, these estimates vary widely depending on definitions used and have not been validated in local cohorts.
Understanding the true burden of insomnia in this population is essential for developing targeted therapeutic strategies that can alleviate symptoms and prevent deterioration in quality of life. This study, PainSomnia, is designed to fill this knowledge gap by providing reliable, population-specific data on the prevalence of chronic insomnia in adults with chronic non-cancer pain.
The results of this study are expected to inform the design of integrated care pathways and public health policies, ensuring that comorbid insomnia is identified early and managed appropriately in individuals with chronic pain.
- Conditions
- Chronic Non-cancer Pain, Insomnia
- Being tested
- Usual care provided from pain specialist or within a dedicated pain unit
- Keywords
- Insomnia, Chronic non-cancer pain, Prevalence
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care provided from pain specialist or within a dedicated pain unitOther
Also called Standard care
Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Usual care provided from pain specialist or within a dedicated pain unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At a single time point during the baseline visit.
Secondary outcomes (12)
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.
Measured: At a single time point during the baseline visit.
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.
Measured: At a single time point during the baseline visit.
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).
Measured: At a single time point during the baseline visit
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.
Measured: At a single time point during the baseline visit
Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant anxiety
This outcome identifies the proportion of patients who meet diagnostic criteria for both chronic insomnia (based on ICSD-3 criteria and ISI score) and clinically significant anxiety (HADS anxiety subscale score ≥11).
Measured: At a single time point during the baseline visit
Proportion of patients with chronic non-cancer pain and clinically significant depression.
Depression will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS). Seven items measure depressive symptoms.
Measured: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain and positive mood.
Mood will be assessed using the Spanish version of the Profile of Mood States (POMS), a 44-item self-reported questionnaire that evaluates six conceptual mood dimensions: Anger (11 items), Fatigue (6), Vigor (5), Friendship (6), Tension (7), and Depressed Mood (9). Each item is scored on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"). Positive mood will be operationalized based on higher scores in the Vigor and Friendship subscales.
Measured: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant depression.
This outcome identifies the proportion of patients who meet criteria for both chronic insomnia (per ICSD-3 and ISI) and clinically significant depression (HADS depression subscale score ≥11).
Measured: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain, chronic insomnia, and positive mood.
This outcome refers to the proportion of patients with both chronic non-cancer pain and chronic insomnia (per ICSD-3 criteria and ISI) who also demonstrate a positive mood, as measured by the Vigor and Friendship subscales of the POMS questionnaire (Spanish version) (Andrade, 2010). Positive mood is defined by higher scores on these subscales, rated on a 0-4 Likert scale.
Measured: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain and reduced well-being or functional capacity.
Health-related quality of life will be assessed using two validated instruments. The SF-12 measures physical and mental health across eight domains using 12 items derived from the SF-36. Scores reflect well-being and functional status. The EQ-5D-3L evaluates five health dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each with three severity levels. Patients reporting moderate or severe problems in at least one EQ-5D-3L domain or scoring low on SF-12 will be classified as having reduced well-being or functional capacity.
Measured: 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.
Among patients with chronic pain and chronic insomnia (per ICSD-3 and ISI), quality of life will be evaluated using the SF-12 and EQ-5D-3L. The SF-12 includes 12 items across eight health dimensions, and the EQ-5D-3L assesses five domains with three levels of severity. Patients reporting moderate or severe impairment in any EQ-5D-3L domain or low SF-12 scores will be categorized as having reduced well-being or functional capacity.
Measured: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain who use benzodiazepines or hypnotic medications.
This outcome captures the proportion of participants with chronic non-cancer pain who report current use of benzodiazepines and/or hypnotic medications at the time of assessment. Medication use will be self-reported by the participant during the baseline visit. Results will be presented as number and percentage of users.
Measured: At a single time point during the baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start9 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Dolor (Catalan Society for Pain), Hospital del Mar
- Responsible party
- Sponsor
- Investigators
- Antonio Montes Pérez, MD, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057232
- Sponsor's protocol ID
- SCD-2024-01
- Acronym
- PainSomnia
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available by the principal investigator upon reasonable request and subject to approval, in accordance with applicable data protection and ethical guidelines.
Publications
Buysse 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.
PubMed 2748771Bastien 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.
PubMed 11438246
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Prevalence of Chronic Insomnia in Patients With Non-cancer Chronic Pain
- ClinicalTrials.gov ID
- NCT07057232
- Acronym / sponsor ID
- PainSomnia / SCD-2024-01
- Conditions
- Chronic Non-cancer Pain, Insomnia
- Keywords
- Insomnia, Chronic non-cancer pain, Prevalence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Societat Catalana de Dolor (Catalan Society for Pain), Hospital del Mar
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
According to ICSD-3, chronic insomnia is characterized by persistent difficulties in initiating or maintaining sleep, or experiencing restorative sleep, occurring at least three times per week for at least three months, despite adequate sleep opportunity and conditions. These disturbances must cause clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning. The thresholds used to define clinical significance-such as sleep onset latency or wakefulness after sleep onset greater than 20 minutes in youth or 30 minutes in older adults-are generally based on subjective reports and clinical observation.
Chronic Pain and Insomnia: A Bidirectional Relationship Historically, insomnia was viewed as a secondary consequence of chronic pain. However, more recent research highlights a bidirectional relationship, where each condition may contribute to and exacerbate the other. Pain can fragment sleep, while disrupted sleep reduces pain thresholds and can trigger spontaneous pain episodes.
Insomnia may act as both a trigger and a perpetuating factor in chronic pain. A landmark sleep deprivation study conducted in 1999 at the University of Washington found that women subjected to selective sleep deprivation exhibited decreased pain tolerance. Since then, multiple studies have confirmed that individuals with insomnia exhibit heightened sensitivity to experimental pain stimuli.
There is strong evidence that short or disrupted sleep can induce hyperalgesia. Additionally, chronic sleep loss has been shown to predict the onset or worsening of chronic pain conditions. Longitudinal studies further support the idea that sleep problems in individuals without existing pain may significantly increase the risk of developing chronic pain syndromes.
The central nervous system has built-in mechanisms to preserve sleep, including neural filtering at the brainstem and descending inhibitory pathways designed to suppress the arousing effects of incoming sensory information. However, pain can override these mechanisms, disrupting both the continuity and architecture of sleep. The extent of this disruption depends on both the intensity of nociceptive stimuli and the individual's susceptibility to sleep fragmentation.
Clinical Relevance and Research Gap Patients with chronic pain are at significantly higher risk for insomnia compared to individuals without pain. The interaction between chronic pain and chronic insomnia is best understood as a vicious cycle in which each condition amplifies the other.
Current clinical guidelines advocate for a multidisciplinary approach to managing chronic pain, which includes addressing associated conditions such as insomnia. Failing to treat insomnia in this population can create a major barrier to effective pain management.
Despite the high co-occurrence of these conditions, no studies to date have quantified the prevalence of chronic insomnia among patients with chronic non-cancer pain in the Spanish population. Although prior studies have estimated the prevalence of sleep disturbances in chronic pain populations to range from 50% to 90%, these estimates vary widely depending on definitions used and have not been validated in local cohorts.
Understanding the true burden of insomnia in this population is essential for developing targeted therapeutic strategies that can alleviate symptoms and prevent deterioration in quality of life. This study, PainSomnia, is designed to fill this knowledge gap by providing reliable, population-specific data on the prevalence of chronic insomnia in adults with chronic non-cancer pain.
The results of this study are expected to inform the design of integrated care pathways and public health policies, ensuring that comorbid insomnia is identified early and managed appropriately in individuals with chronic pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic non-cancer pain patients | – | Other: Usual care provided from pain specialist or within a dedicated pain unitAdult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care provided from pain specialist or within a dedicated pain unitAlso: Standard careAdult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit | Other | Chronic non-cancer pain patients |
Primary outcome
Proportion of patients with chronic non-cancer pain and insomnia
Time frame: 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).
12 secondary outcomes
Proportion of patients with chronic non-cancer pain and moderate/severe pain intensity (>4).
Time frame: At a single time point during the baseline visit.
Proportion of patients with moderate to severe chronic non-cancer pain intensity, and chronic insomnia.
Time frame: At a single time point during the baseline visit.
Proportion of patients with poor sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: At a single time point during the baseline visit
Proportion of patients with chronic non-cancer pain and clinically significant anxiety
Time frame: At a single time point during the baseline visit
Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant anxiety
Time frame: At a single time point during the baseline visit
Proportion of patients with chronic non-cancer pain and clinically significant depression.
Time frame: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain and positive mood.
Time frame: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain, chronic insomnia, and clinically significant depression.
Time frame: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain, chronic insomnia, and positive mood.
Time frame: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain and reduced well-being or functional capacity.
Time frame: 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.
Time frame: At a single time point during the baseline visit.
Proportion of patients with chronic non-cancer pain who use benzodiazepines or hypnotic medications.
Time frame: At a single time point during the baseline visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 11438246Bastien 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.
- Individual participant dataSharing planned: Yes. IPD will be made available by the principal investigator upon reasonable request and subject to approval, in accordance with applicable data protection and ethical guidelines.
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A Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Participants With Moderate-to-Severe Non-Cancer Chronic Pain
Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Montes Pérez, MD, PhD principal investigator
Hospital del Mar
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Non-cancer Pain and Insomnia, run by Germans Trias i Pujol Hospital at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Montes Pérez, MD, PhD (+34 932 48 30 00, amontes@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with chronic non-cancer pain and insomnia (time frame: At a single time point during the baseline visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07057232, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.