Concept: Contribution of Sleep Disturbances to Chronic Pain Initiative

Project Concept Review

Council Date: February 5, 2016

Program Officer: Robin Boineau, M.D., M.A.

Background

Chronic insomnia and chronic pain are overlapping health conditions that impact approximately half of the adult population. There is substantial clinical evidence that chronic pain states affect sleep. Emerging evidence indicates that sleep may more strongly predict the development of chronic pain rather than pain predicting sleep disturbances. NCCIH held a workshop, “Contribution of Sleep Disturbances to Chronic Pain,” in May 2014 to explore this dynamic.

The areas discussed during the workshop that need to be addressed in future research include:

• Increase knowledge of the cells, systems, pathways, and genetic and molecular mechanisms operating at the interface of sleep and pain, which may have the potential to lead to discovery of novel or augment existing pharmacologic and nonpharmacologic treatment approaches.
• Biomarkers need to be developed to help identify risk of developing chronic pain, serve as novel treatment-modifiable outcome measures, and represent targets for interventions.
• Mind-body studies, such as mindful cognitive behavioral therapy and complementary and integrative approaches could be further evaluated in clinical studies, perhaps in conjunction with pharmacologic approaches, to alleviate sleep disturbances and consequent pain.
• Natural product interventions should be tailored to the particular condition and target population.
• Treatments that can transition from testing to delivery relatively quickly, are safe and low-cost, and are effective in real-world settings are critically needed.
• Study design and methodology issues that would enhance future clinical studies.

Purpose of Proposed Initiative

The purpose of the proposed initiative is to advance NCCIH interests to study the contribution of sleep disturbances to chronic pain, especially how sleep disturbances impact pain, and to determine whether alleviating sleep disturbances reduces or prevents development of chronic pain. Program proposes a multistep approach to reach this overall goal. The proposed steps are to develop funding opportunities to: (1) add supplemental funds to ongoing sleep and/or pain research grants supported by NIH to allow investigators to add sleep variables to ongoing clinical research evaluating chronic pain or to add pain variables to ongoing clinical sleep research; (2) partner with other NIH Institutes and Centers to support mechanistic research to improve the understanding of the interaction of sleep’s influence on chronic pain; and (3) to support clinical research to develop and refine interventions to improve sleep and reduce chronic pain, or when preliminary data is adequate support clinical trials to evaluate the efficacy or effectiveness of complementary and integrative approaches.

Objectives

Step one is to develop a program announcement that would permit adding supplemental funds to ongoing NIH-funded research in sleep or pain to allow addition of: sleep variables to clinical studies of pain; pain variables to clinical studies of sleep; or funding partnerships to further explore the dynamic of sleep disturbances influencing chronic pain. Additional steps are to develop funding mechanisms with other ICs interested in advancing sleep-pain mechanistic research for mechanistic studies of sleep disturbances and chronic pain. Finally, we propose a multistage funding announcement for clinical studies of sleep-pain research of natural products, and/or mind-body interventions.

The benefits of this multiple step approach include:

• Helps in communicating our interests in pursuing research in this area to the scientific community.
• Rapid approach to initiate a portfolio in this area by funding initially as supplements to ongoing NIH projects in sleep and/or pain research with populations identified for that work.
• Opportunity to build momentum and preliminary data for researchers investigating sleep or pain by adding data collection on sleep/pain variables.

An example of a potential study that could utilize such a supplement is R01 AT008336. This is a study of hypnosis and meditation for pain management in veterans. The investigators have identified sleep as an important variable, but because it is not a primary outcome they are only collecting patient-reported outcomes of sleep. They have recently begun enrollment with plans to recruit 343 veterans. Supplemental funds could be used to assess the evaluation of sleep in a more objective way and longitudinally to determine changes in sleep mediated pain outcomes.