Chronic Insomnia in Non-Cancer Pain Patients

NCT07057232 | Recruiting

• 1 other identifier: SCD-2024-01
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 15

Brief 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. 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

Chronic Non-cancer Pain; Insomnia

Keywords

Insomnia; Chronic non-cancer pain; Prevalence

Outcome Measures

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).

  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).

  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

Study Arms (1)

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.

Other: Usual care provided from pain specialist or within a dedicated pain unit

Interventions

Usual care provided from pain specialist or within a dedicated pain unit OTHER

Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit

Also known as: Standard care

Chronic non-cancer pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult non-cancer chronic pain patients receiving care in outpatient settings from a pain specialist or within a dedicated pain unit.

You may qualify if:

• 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

You may not qualify if:

• Deemed unable or unlikely to cooperate adequately with study procedures at the discretion of the pain specialist or investigator

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Societat Catalana de Dolor (Catalan Society for Pain): collaborator
• Hospital del Mar: collaborator

Study Sites (15)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

ACTIVE NOT RECRUITING

Instituto de Medicina y Cirugía

Barcelona, Catalonia, 08022, Spain

ACTIVE NOT RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

ACTIVE NOT RECRUITING

Hospital del Mar

Barcelona, Catalonia, 08916, Spain

ACTIVE NOT RECRUITING

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

ACTIVE NOT RECRUITING

Hospital de Viladecans

Hospitalet Del Llobregat, Catalonia, 08840, Spain

ACTIVE NOT RECRUITING

Hospital Universitari de Bellvitge

Hospitalet Del Llobregat, Catalonia, 08907, Spain

ACTIVE NOT RECRUITING

Centre Avantmèdic Ponent

Lleida, Catalonia, 25008, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

ACTIVE NOT RECRUITING

Complex Hospitalari Moisés Broggi

Sant Joan Despí, Catalonia, 08970, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Joan XXIII

Tarragona, Catalonia, 43005, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Sant Joan de Reus

Tarragona, Catalonia, 43204, Spain

ACTIVE NOT RECRUITING

Hospital de Tortosa Verge de la Cinta

Tarragona, Catalonia, 43500, Spain

ACTIVE NOT RECRUITING

Consorci Sanitari de Terrassa

Terrassa, Catalonia, 08227, Spain

ACTIVE NOT RECRUITING

Related Publications (2)

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Antonio Montes Pérez, MD, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 9, 2025
• Study Start: June 9, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be made available 6 months after study completion and will remain available for up to 5 years upon request.
• Access Criteria: Qualified researchers may request access to de-identified IPD for secondary analyses that are consistent with the original study objectives. Requests must include a research proposal and data use agreement, and will be reviewed by the principal investigator. Data will be shared in compliance with applicable ethical and legal standards.

Locations

ES (15)