Status:
RECRUITING
Promoting Sleep to Alleviate Pain - Arthroplasty
Lead Sponsor:
Uppsala University
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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...
Detailed Description
Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to ta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06145516
Start Date
September 1 2025
End Date
December 1 2030
Last Update
July 9 2025
Active Locations (1)
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1
Department of Surgical Sciences, Uppsala University
Uppsala, Uppland, Sweden, 75185