Actively Recruiting
Promoting Sleep to Alleviate Pain - Arthroplasty
Led by Uppsala University · Updated on 2026-05-06
100
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Promoting Sleep to Alleviate Pain - Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Insomnia severity index score greater than 10
- Meet DSM-V criteria for persistent insomnia disorder
- Average pain score of 4 or higher on a 0 to 10 scale, at rest or after 5 minutes of walking
- Scheduled for primary total knee or hip arthroplasty due to osteoarthritis
You will not qualify if you...
- Uncontrolled medical disorders
- Nightshift work
- Current major depressive disorder, bipolar disorder, psychotic disorder, or substance dependence
- History or high likelihood of primary sleep disorders other than insomnia (e.g., obstructive sleep apnea, narcolepsy, nocturnal myoclonus)
- Severe vision impairment that prevents participation in study interventions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Surgical Sciences, Uppsala University
Uppsala, Uppland, Sweden, 75185
Actively Recruiting
Research Team
M
Martin F Bjurström, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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