Chronic Pain Sleep Inventory (CPSI)
Pain and Sleep Questionnaire (PSQ-3)
The Chronic Pain Sleep Inventory© (CPSI©), sometimes referred to as the Pain and Sleep Questionnaire© (PSQ-3©) is a 5-item proprietary self-administered sleep questionnaire protected by copyright. It is a widely used tool to evaluate the role of pain in sleep interference, both in analgesic clinical trials and clinical practice. CPSI Version 2.0 (CPSI-3©), sometimes referred to as PSQ-3© uses 3 of the 5-items where all items attribute sleep problems to pain to form a unidimensional construct. The preferred name of this instrument is Chronic Pain Sleep Inventory© (CPSI©) or CPSI Version 2.0 (CPSI-3©).
Why Assess Sleep in Analgesic Clinical Trials?
Patients with chronic pain, including cancer pain, musculoskeletal pain (e.g., osteoarthritis, low back pain), fibromyalgia and neuropathic pain (e.g., painful diabetic neuropathy, postherpetic neuralgia and painful HIV associated neuropathy) frequently present with a wide variety of comorbid pathologies that may or may not be causally related to their chronic pain. Self-reports and polysomnographic findings have long suggested that sleep disturbances are common in patients with chronic pain, with higher pain intensity scores correlating with greater sleep impairment. However, until relatively recently, efficacy outcomes in clinical trials focused only on relief from pain, joint stiffness and improvements in physical function. Furthermore, there was little information on the epidemiology of sleep disturbance in chronic pain and on the effects of analgesic treatment on sleep impairment.
General Description of the CPSI and PSQ-3
The CPSI and CPSI Version 2.0 (CPSI-3), sometimes referred to as the Pain and Sleep Questionnaire (PSQ-3) are proprietary sleep questionnaires protected by copyright. They were developed in the English language (U.S.) and have undergone translation in approximately two dozen languages. They have been used to successfully document the effects of therapeutic interventions on various sleep characteristics in randomized clinical trials by numerous pharmaceutical companies and included in New Drug Applications (NDAs) as VAS and Lickert scales, in paper and electronic form.
Available Languages
The Chronic Pain Sleep Inventory© (CPSI©) and the CPSI Version 2.0 (CPSI-3©), sometimes referred to as PSQ-3© was developed in English for the USA and is available in 23 languages. The listed translations may not have undergone a full linguistic validation process and may require further work to be suitable for use in a study. This list is subject to constant changes, therefore please check the status of translations or contact us using this link to the Contact Form.
| Country | Language | Country | Language | Country | Language |
|---|---|---|---|---|---|
| Austria | German | Germany | German | Slovak | Slovakian |
| Belgium | Dutch/French | Italy | Italian | Slovenia | Slovenian |
| Bulgaria | Bulgarian | Latvia | Latvian/Russian | Spain | Spanish |
| Croatia | Croatian | Poland | Polish | UK | English |
| Czech Rep | Czech | Romania | Romanian | Ukraine | Ukrainian |
| Denmark | Danish | Russia | Russian | Ukraine | Russian |
| France | French | Serbia | Serbian | USA | English |
Author
The Chronic Pain Sleep Inventory© (CPSI©), CPSI Version 2.0 (CPSI-3©) and PSQ-3© were developed by Najib Babul, PharmD, MBA, an experienced drug development consultant with strategic, scientific and operational expertise across a variety of therapeutic areas. Dr. Babul has designed and overseen the development of numerous new and repurposed drugs using the 505(b)(1) and 505(b)(2) regulatory pathways. Previously, he was (i) VP, Clinical Development at Cadence Pharmaceuticals (now a part of Mallinckrodt), (ii) Chief Scientific Officer at TheraQuest Biosciences; (iii) VP, Global Clinical Drug Development & Therapeutic Leader, Analgesia & Rheumatology at SCIREX, a CRO (now Premier Research) and (v) Director, Clinical Research at Purdue Pharma. He has been an invited speaker at FDA and FDA Advisory Committee and has served as an advisor to pharmaceutical companies and investment banks in the U.S., Europe and Japan. Dr. Babul has published ≥ 180 abstracts and manuscripts in leading medical journals and scientific proceedings, including the Neurology, Lancet, JAMA, Journal of Clinical Oncology, Cancer, Journal of Clinical Pharmacology, Pain, Anesthesiology, Anesthesia & Analgesia, Journal of Palliative Care, Clinical Pharmacology & Therapeutics and European Journal of Pharmaceutical Sciences. He received his B. Pharm. from the University of British Columbia, PharmD from the State University of New York, Buffalo and MBA from the California Institute of Advanced Management
Conditions of Use
The Chronic Pain Sleep Inventory© (CPSI©), CPSI Version 2.0 (CPSI-3©) and PSQ-3© are proprietary sleep questionnaires protected by copyright. Licensing processes and costs are determined based on information specific to each research project.
Students, Physicians, Clinical Practice, Not-Funded Academic Users
No charge, subject to execution of a license and copyright agreement. To obtain permission, a request may be submitted using the License Request. We will get back to you with the needed information and license agreement in a timely manner. If you require immediate assistance, please use the Contact Form.
Funded Academic Users, Commercial Users & IT Companies
Costs are determined on the basis of information specific to each research project. Use is subject to a license and copyright agreement. To obtain permission, a request may be submitted using the License Request. We will get back to you with the needed information and license agreement in a timely manner. If you require immediate assistance, please use the Contact Form.
Bibliography
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Babul N, Noveck R. Chronic Pain Sleep Inventory for evaluation of treatment responses to opioid analgesics: randomized, placebo- controlled clinical trials in OA. Proceedings of the CHANGE “Copyright© 1997 – 2019 …… affiliates. All Rights Reserved. Chronic Pain ……. or its affiliates.” TO Copyright© 1997-2021, Cinergen, LLC or its affiliates. All Rights Reserved. Chronic Pain Sleep Inventory is a registered trademark and copyright property of Cinergen, LLC or its affiliates.”
American Pain Society 22nd Annual Scientific Meeting, March 20-23, 2003, Chicago, Illinois.