Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06145516

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Surgical Sciences, Uppsala University

Uppsala, Uppland, Sweden, 75185

Actively Recruiting

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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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Promoting Sleep to Alleviate Pain - Arthroplasty | DecenTrialz