Promoting Sleep to Alleviate Pain - Arthroplasty

NCT06145516 · tracked via the Priya Life Science Sweden tracker

Sponsor

Uppsala University

Phase

Not applicable

Started

2025-09-01

Last updated

2026-05-06

Condition(s) studied

Osteoarthritis, KneeOsteoarthritis, HipInsomniaSurgeryPain, PostoperativePostoperative Complications

Investigational drug(s) / intervention(s)

Cognitive behavioral therapy for insomnia (CBT-I)Sleep education therapy (SET)

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)

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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)

Primary outcome measure(s)

Acute postoperative pain intensity — First 7 postoperative days
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days

Trial sites (1)

Facility	City	Region	Status
Department of Surgical Sciences, Uppsala University	Uppsala	Uppland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06145516 on ClinicalTrials.gov ↗ ← All trials in Sweden