Promoting Sleep to Alleviate Pain - Arthroplasty
Recruiting now · Not applicable
Conditions studied: Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications
In brief
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.
Key facts
- Study ID
- NCT06145516
- Run by
- Uppsala University
- People needed
- 100
- Starts
- 2025-09-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis
You may not qualify if…
- 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
- severely impaired vision (precluding ability to take part of study interventions)
Where it is running
- Department of Surgical Sciences, Uppsala University — Uppsala, Uppland, Sweden (enrolling)
Full record on ClinicalTrials.gov
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