PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.
age ≥18 years
insomnia severity index score >10
fulfill DSM-V criteria for persistent insomnia disorder
average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and/or movement-related pain NRS score ≥4 after 5 minutes walking
uncontrolled medical disorders
nightshift work
ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence
current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus
Uppsala University
Lead sponsor