Use of patient-reported sleep measures in clinical trials of pain treatment: A literature review and synthesis of current sleep measures and a conceptual model of sleep disturbance in pain

Cole, Jason C.; Dubois, Dominique; Kosinski, Mark

doi:10.1016/j.clinthera.2007.12.005

Cited by 82Sleep and related disordersMusculoskeletal pain and rehabilitationObstructive Sleep Apnea Research

Use of patient-reported sleep measures in clinical trials of pain treatment: A literature review and synthesis of current sleep measures and a conceptual model of sleep disturbance in pain

Cole, Jason C., Dubois, Dominique, Kosinski, Mark·2007·Clinical Therapeutics

DOI 10.1016/j.clinthera.2007.12.005

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Abstract

Background Despite the strong relationship between sleep-related problems and chronic pain, no measures have been developed specifically for the assessment of sleep disorders in patients with chronic pain. In addition, there are no explicit guidelines to suggest which of the existing self-reported measures of sleep disorders best capture the sleep disorders pertinent to patients with chronic pain. Objective The objective of this paper was to examine the fit between current sleep measures that capture areas of sleep disturbance important to patients with pain and to develop a conceptual model of sleep disturbance in these patients. Methods A conceptual framework describing the associations between patient-reported experiences of pain and sleep problems was constructed based on a review of the published peer-reviewed literature. The online OVID/MEDLINE and PubMed databases were searched for articles in English published between 1995 and June 2007. Additional relevant material was identified by searching the reference lists of systematic review articles. The literature review and conceptual framework were used to determine the sleep domains that are most relevant to the study of patients with chronic pain. The patient-reported sleep measures most frequently used in pain clinical trials were identified and characterized psychometrically, along with how well they captured the relevant sleep domains. Results Fourteen pain trials were identified in which sleep instruments were used.…

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The PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients.
“The PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients.13”
From Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. (2017) · cites this paper as Cole et al., 2007

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Background
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Background
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“Fifty to seventy percent of patients with chronic pain report sleep interruption, with most of these patients citing pain as the primary cause of sleep disruption (4).”
A Preliminary Study of Cigarette Smoking in Female Orofacial Pain Patients
Burris, J. L., Perez, C. V., Evans, D. R., & Carlson, C. (2013) · Behavioral Medicine · doi:10.1080/08964289.2012.731439 · Cited by 8 · see citing works
Gender differences in variables associated with sleep quality in chronic tension type headache
Cigarán-Méndez, M., Fernández-Muñoz, J. J., Navarro-Pardo, E., Jiménez-Antona, C., Parás-Bravo, P., Alburquerque-Sendín, F., & Fernández-de-las-Peñas, C. (2018) · Women & health · doi:10.1080/03630242.2017.1372845 · Cited by 7 · see citing works
Factors Associated With Sleep Quality in Patients With Chronic Widespread Pain Attending Multidisciplinary Treatment
de Rooij, A., van der Leeden, M., Roorda, L. D., Rinkema, M., Beuving, W., & Dekker, J. (2020) · Pain Practice · doi:10.1111/papr.12873 · Cited by 6 · see citing works
“The PSQI is widely used in various samples with chronic pain and shows adequate psychometric properties.(26,27)”
Method
PRACTICAL CHRONIC PAIN ASSESSMENT TOOLS IN CLINICAL PRACTICE
Lončarić–Katušin, M., Milošević, M., Žilić, A., Mišković, P., Majerić-Kogler, V., & Žunić, J. (2016) · Acta Clinica Croatica · doi:10.20471/acc.2016.55.s1.02 · Cited by 6 · see citing works
Assessing Sleep Problems of Older Adults
Trevorrow, T. (2010) · Elsevier eBooks · doi:10.1016/b978-0-12-374961-1.10016-8 · Cited by 2 · see citing works
How to personalise cognitive–behavioural therapy for chronic primary pain using network analysis: study protocol for a single-case experimental design with multiple baselines
Hofmann, V. E., Glombiewski, J. A., Kininger, F., & Scholten, S. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-089319 · Cited by 5 · see citing works
Structural abnormalities of brain electrical activity during night sleep in patients with obstructive apnoea syndrome
Евгеньевна, Р. А., Zhuravlev, M. О., Orlova, A. A., Викторович, А. М., Drapkina, O. M., & Kiselev, A. R. (2023) · The European Physical Journal Special Topics · doi:10.1140/epjs/s11734-023-01056-4 · Cited by 9 · see citing works
Patient Profiling Based on Spectral Clustering for an Enhanced Classification of Patients with Tension-Type Headache
Pellicer-Valero, Ó., Fernández-de-las-Peñas, C., Martín-Guerrero, J., Navarro-Pardo, E., Cigarán-Méndez, M., & Florêncio, L. (2020) · Applied Sciences · doi:10.3390/app10249109 · Cited by 5 · see citing works
“The PSQI has shown good internal consistency (Cronbach α 0.83) and test-retest reliability (r = 0.73) [25].”
MethodInfluential
Subjective sleep disturbances at the time of diagnosis in patients with polymyalgia rheumatica and in patients with seronegative elderly-onset rheumatoid arthritis. A pilot study
Manzo, C., & Castagna, A. (2020) · Rheumatology · doi:10.5114/reum.2020.98430 · Cited by 5 · see citing works
“The MOS-SS psychometric properties have been evaluated in patients with a variety of conditions characterized by pain; in particular, it is considered the best choice in assessing sleep impairment due to pain [22, 23].”
Background
Association Between Pharmacotherapy and Sleep Quality in Patients with Chronic Orofacial and Chronic Body Pain: A Cross-Sectional Study
Bavia, P. F., Khawaja, S. N., de la Rosa, M. F. H.-N., Tseng, L. A., & Keith, D. A. (2023) · Journal of Pain Research · doi:10.2147/jpr.s412459 · Cited by 4 · see citing works
Variables associated with sleep quality in chronic tension-type headache: A cross-sectional and longitudinal design
Benito-González, E., Palacios-Ceña, M., Fernández-Muñoz, J. J., Castaldo, M., Wang, K.-L., Catena, A., Arendt-Nielsen, L., & Fernández-de-las-Peñas, C. (2018) · PLoS ONE · doi:10.1371/journal.pone.0197381 · Cited by 4 · see citing works
“The main outcome, sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI), one of the questionnaires most commonly used [19].”
BackgroundMethod
Various types of sleep disturbance due to different sorts of low back pain. A literature review: 2. A single insomnia severity measure and multiple insomnia items
Sweetman, B. (2015) · International Musculoskeletal Medicine · doi:10.1179/1753614615z.00000000098 · Cited by 3 · see citing works
Kriterien der Schlafqualität
Fischer, J. (2009) · Deutsche Medizinische Wochenschrift · doi:10.1055/s-0029-1222587 · Cited by 3
Enhancing Sleep Quality: The Impact of the “Repose Tao” Pillow with Taopatch® Nanotechnology—A Pilot Study
Campoli, F., Orofino, F., Messina, G., Corrado, D. D., & Francavilla, V. (2025) · Clocks & Sleep · doi:10.3390/clockssleep7030032 · Cited by 1 · see citing works
“This effect is particularly valuable for individuals’ experiencing insomnia or delayed sleep phase syndrome, as reduced sleep latency is closely linked to better overall sleep quality [46,47].”
Psychometric properties of the MOS sleep scale in Turkish patients with knee osteoarthritis: A methodological validation study
Sezgin, M., Yeşildal, E., Sarıkaya, P., Ankaralı, H., & Şahin, G. (2026) · Journal of Back and Musculoskeletal Rehabilitation · doi:10.1177/10538127261419539
“24 The original English version of the MOS sleep scale has been demonstrated to be valid and reliable in both the general population and patients with neuropathic pain.”
Does a Multidisciplinary Pain Management Treatment Improve Sleep Quality in Patients with Chronic Widespread Pain and Sleep Problems? Results from the AMS-Pain Cohort
de Rooij, A. (2024) · Journal Of Rehabilitation And Pain Medicine · doi:10.37191/mapsci-jrpm-1(3)-014
“In part one a standard package of treatment was offered and consisted of the following modules: [28,29].”
Background
Legal ramifications of the ADA Protocol on sleep-related breathing disorders (SRBD)
Berley, K. (2019) · Cranio · doi:10.1080/08869634.2019.1664505
“Sleep problems occur in 50–89% of patients with some type of chronic pain [3,4], and up to 90% of patients with TMD commonly report poor sleep quality [6].”
Background
Sleep Impairment at the Time of First Diagnosis in Patients with Seronegative Elderly-Onset Rheumatoid Arthritis and in Patients with Polymyalgia RheumaticaPreprint
Manzo, C., & Castagna, A. (2019) · Preprints.org · doi:10.20944/preprints201902.0199.v1
“MOS-SS is 50 considered the first choice in assessing the sleep impairment due to pain [14,15].”
Background
Assessing insomnia in pain – Can short be good?
Mäntyselkä, P. (2015) · Scandinavian Journal of Pain · doi:10.1016/j.sjpain.2015.07.001
Sleep in older adults
Neikrug, A. B., Lu, Y., Chao, T., & Ancoli‐Israel, S. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-822963-7.00209-7
Contribution of Sleep Disturbance to Cancer Fatigue
Miaskowski, C., & Aouizerat, B. (2014) · Springer eBooks · doi:10.1007/978-1-4614-9527-7_9

Authors: Cole, J. C., Dubois, D., & Kosinski, M.
Affiliations: Janssen (Belgium) (BE)
Corresponding author: Cole, Jason C.
ORCID: Dubois, Dominique
Kosinski, Mark
Venue: Clinical Therapeutics
Publisher: Elsevier BV
Published: 2007-01
Volume: 29
Issue: 11
Pages: 2580-2588
ISSN: 0149-2918 (ISSN-L)
DOI: 10.1016/j.clinthera.2007.12.005
OpenAlex: W1981207099
Cited by: 82
References: 0
Citations by year: 2026: 1 · 2025: 1 · 2024: 3 · 2023: 4 · 2022: 2 · 2021: 4 · 2020: 6 · 2019: 7 · 2018: 4 · 2017: 6 · 2016: 6 · 2015: 4 · 2014: 5 · 2013: 6 · 2012: 7
FWCI: 4.69
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Clinical Therapeutics (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
Keywords: sleep disorders, chronic pain, patient-reported outcomes, Pittsburgh Sleep Quality Index, psychometric properties, factor structure
MeSH terms: Clinical Trials as Topic, Humans, Pain, Sleep Wake Disorders

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Use of patient-reported sleep measures in clinical trials of pain treatment: A literature review and synthesis of current sleep measures and a conceptual model of sleep disturbance in pain

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