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Promoting Sleep to Alleviate Pain - Arthroplasty

NCT06145516 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
  • Insomnia
  • Surgery
  • Pain, Postoperative
  • Postoperative Complications

Interventions

BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-I)

Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)

BEHAVIORAL

Sleep education therapy (SET)

Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Martin F Bjurström, MD, PhD · Uppsala University / Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2029-12-01
Completion
2030-12-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06145516 on ClinicalTrials.gov