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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Antonio Montes Pérez, MD, PhD contact

+34 932 48 30 00

amontes@psmar.cat

Sebastián Videla Cés, MD, PhD contact

+34 934 65 12 00

svidelac.germanstrias@gencat.cat

15 sites in 1 country

Spain15 sites, 1 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

    Active, not recruiting
  • Centre Avantmèdic Ponent

    Lleida, Catalonia, 25008

    Mercè Matute, MD, PhD, 973 72 80 90, mmatute@comll.cat

    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

    Active, not recruiting

Other trials in Spain

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.

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 groups in NCT07057232
Study groupRoleWhat they receive
Chronic non-cancer pain patientsAdult 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.

  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).

    Measured: At a single time point during the baseline visit.

Secondary outcomes (12)
  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.

    Measured: 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.

    Measured: 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).

    Measured: At a single time point during the baseline visit

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  1. First posted9 Jul 2025
  2. Study start9 Jun 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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 2748771
  • Bastien 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

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.

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