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| Funder | NATIONAL INSTITUTE ON AGING |
|---|---|
| Recipient Organization | Johns Hopkins University |
| Country | United States |
| Start Date | Aug 01, 2024 |
| End Date | Jul 31, 2029 |
| Duration | 1,825 days |
| Number of Grantees | 2 |
| Roles | Co-Investigator; Principal Investigator |
| Data Source | NIH (US) |
| Grant ID | 10819719 |
Preventing Chronic Postsurgical Pain (CPSP) and reducing postsurgical opioid exposure is a public health imperative. Perioperative insomnia is an increasingly recognized modifiable risk factor for CPSP and opioid usage, but studies have yet to evaluate whether treating insomnia perioperatively reduces CPSP and opioid
exposure. Insomnia has been linked to central nervous system alterations that contribute to the transition from acute to chronic pain and is prevalent in at least 50% of older adults with knee osteoarthritis (KOA), awaiting total knee arthroplasty (TKA). Currently, TKA for end stage KOA is the most common elective surgical
procedure in the US. Rates of CPSP after TKA are high with ~ 20% of individuals reporting moderate to severe CPSP. Research determining whether optimizing sleep improves TKA outcomes is critical because TKAs are estimated to increase exponentially to 3.5 million per annum in the next decade. Benzodiazepine receptor
agonists, the most commonly used therapies for insomnia are contraindicated in older adults and especially dangerous in the context of opioid pain management. Cognitive-behavioral therapy for insomnia (CBTi), is a safe, well-established treatment for insomnia that improves sleep in chronic pain and has demonstrated small,
but significant effects on pain severity that require enhancement. Emerging data suggests that morning bright light treatment (MBLT) not only improves circadian rhythms and sleep, it has mood enhancing and analgesic properties. Although both CBTi and MBLT have distinct mechanisms of action, research on their combination is
just emerging and neither has been used to prevent CPSP or reduce opioid use. We propose a randomized, controlled, parallel arm, clinical trial, to test the effects of CBTi and CBTi+MBLT on CPSP and opioid sparing following TKA. Five weeks prior to surgery, TKA patients with insomnia will be randomized to one of 3
conditions matched on timing and contact duration: 1) CBTi+placebo [four pre-surgical telehealth sessions + two post-TKA boosters (2-week and 3 mo. post TKA)] with 1-hour daily morning deactivated ion generator sham exposure (placebo) for 4-wks. pre and 4-wks. post-surgery; 2) CBTi+MBLT (1-hour daily morning bright
light treatment for 4-wks. pre and 4-wks. post-surgery), and 3) Education (EDU)+placebo with 1-hour daily morning deactivated ion generator exposure (4-wks. pre and 4-wks. post-surgery). Outcomes will be assessed at baseline, post CBT-I (pre-surgery), 6-weeks, 3, and 6-months post-surgery. We have three aims: 1) To
evaluate the effects of perioperative CBTi+placebo and CBTi+MBLT on CPSP [(3-6 mos.) primary] and opioid use [(6 weeks-6 mos.) 2ndry]; 2) To examine the effects of CBTi+placebo and CBTi+MBLT on pre-surgical, acute post-surgical (6-weeks), and chronic (3, 6 months) insomnia symptom severity, circadian rest activity
rhythm (RAR), and depressed mood; 3) (exploratory) Evaluate whether the effects of treatment condition on CPSP and opioid use from 3 to 6 months post-TKA are partially mediated by improvements in insomnia severity, increases in circadian RAR strength and decreases in depressed mood at 6-weeks post-TKA.
Johns Hopkins University
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