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New treatment option for Osteoarthritis, Knee
Official title Promoting Sleep to Alleviate Pain - Arthroplasty
ClinicalTrials.gov ID: NCT06145516
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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 likely can't join 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...
- severely impaired vision (precluding ability to take part of study interventions)
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Uppland, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Uppland, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.