NCT06145516 Promoting Sleep to Alleviate Pain - Arthroplasty
| NCT ID | NCT06145516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Martin F Bjurström, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University / Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT06145516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06145516 currently recruiting?
Yes, NCT06145516 is actively recruiting participants. Contact the research team at martin.flores.bjurstrom@uu.se for enrollment information.
Where is the NCT06145516 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT06145516 clinical trial?
NCT06145516 is sponsored by Uppsala University. The principal investigator is Martin F Bjurström, MD, PhD at Uppsala University / Uppsala University Hospital. The trial plans to enroll 100 participants.