Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Improving sleep to reduce pain after joint surgery

Official title: Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial

Run by Uppsala University · NCT06145516 · Data updated 2026-11-12

This study is testing if helping people with insomnia sleep better before knee or hip surgery can reduce their pain after the operation.

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment100 (estimated)
SponsorUppsala University
Academic / other
Locations1 site (Uppsala, Uppland)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedDecember 1, 2029
Study endsDecember 1, 2030
Registry record updatedMay 6, 2026
Trial IDNCT06145516 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with significant insomnia symptoms who are scheduled for total knee or hip arthroplasty.

Probably not a fit

Patients with uncontrolled medical disorders, severe psychiatric conditions, or primary sleep disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of preoperative sleep promotion on pain control in patients undergoing total knee or hip arthroplasty. Participants with significant insomnia will be randomized to receive either cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy over a four-week period before their surgery. The study aims to evaluate both acute and long-term postoperative outcomes, including pain management, sleep quality, mental health, and cognitive function. Participants will be monitored through questionnaires and on-site visits at various stages of the study.

Why it matters

Potential benefit: If successful, this approach could lead to improved pain management and recovery for patients undergoing joint replacement surgeries.

How similar studies have gone: While there is limited research specifically targeting preoperative sleep for postoperative outcomes, similar approaches in managing insomnia have shown promise in other contexts.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Department of Surgical Sciences, Uppsala University
    Uppsala, Uppland, Sweden
    Recruiting

Study contacts

  • Principal investigator: Martin F Bjurström, MD, PhD — Uppsala University / Uppsala University Hospital
  • Study coordinator: Martin F Bjurström, MD, PhD
  • Email: martin.flores.bjurstrom@uu.se
  • Phone: +46739512728

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.