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NCT Number: NCT06145516

Promoting Sleep to Alleviate Pain - Arthroplasty

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgical Sciences, Uppsala University

Uppsala, Uppland, 75185, Sweden

Location status: Recruiting

Location contact

Andrea Niklasson, M.D.

CONTACT

[email protected]

0046186122110

Martin F Bjurström, Associate Professor

PRINCIPAL_INVESTIGATOR

About this study

Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to target preoperative sleep to achieve improved postoperative outcomes. This study addresses two chronic pain populations, TKA and THA patients, that suffer severely due to both sleep disturbance and painful symptoms. Patients who meet eligibility criteria, including insomnia severity index score >10 and confirmed DSM-V criteria for persistent insomnia disorder, will be randomized to a brief, hybrid version of CBT-I or sleep education therapy over a 4-week period, before surgery. The CBT-I will focus on the two components which have shown the highest efficacy for sleep improvement, sleep restriction therapy and stimulus control. The CBT-I treatment will be administered in self-guided digital format with addition of telehealth video-consultations with a psychologist one time per week. The sleep education therapy will also be provided in a hybrid format, including digital sessions and video-consultations with a research nurse. There will also be a booster session 1-2 weeks postoperative for both interventions. Participants will be carefully evaluated during on-site visits two times preoperative, pre- and post-intervention, and one time 6 months postoperative. During on-site visits, participants will complete multiple questionnaires (covering pain, pain catastrophizing, mental health, physical function, activity etc), undergo digital cognitive testing, quantitative sensory testing (QST, to determine pain detection thresholds to different stimuli, assess temporal summation, pain inhibitory capacity), provide blood samples, and initiate actigraphy (objective assessment of sleep continuity measures). In addition to the on-site visits, participants will complete questionnaires remotely 3 and 12 months after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

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

Sleep education therapy (SET)

Behavioral

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

Primary outcomes

  1. Acute postoperative pain intensity

    Time frame: First 7 postoperative days

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

Secondary outcomes

  1. Pre- and acute postoperative change in sleep measures from baseline

    Time frame: Up to 2 weeks postoperative

    insomnia severity index, Pittsburgh sleep quality index, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency)

  2. Acute postoperative opioid consumption

    Time frame: Postoperative day (POD) 1 and POD1-7

    Oral morphine mg equivalents (OMEQs)

  3. Recovery in the acute postoperative phase

    Time frame: First 7 postoperative days

    Quality of recovery (QoR) 15 score

  4. Long-term postoperative sleep quality

    Time frame: Up to 12 months postoperative

    insomnia severity index

  5. Postoperative objective sleep continuity

    Time frame: Up to 6 months postoperative

    actigraphic sleep efficiency [SE]

  6. Pain intensity 6 months postoperative

    Time frame: 6 months postoperative

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

  7. Change in pain measures from baseline

    Time frame: Up to 12 months postoperative

    BPI pain severity and pain interference score, QoR-15 pain score, WOMAC OA pain score

  8. Changes in quantitative sensory testing (QST) measures of pain

    Time frame: Up to 6 months postoperative

    Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test

  9. Change in cognitive function

    Time frame: Up to 6 months postoperative

    Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions

  10. Change in anxiety from baseline

    Time frame: Up to 6 months postoperative

    Generalized anxiety disorder 7 (GAD-7) score

  11. Change in depression from baseline

    Time frame: Up to 6 months postoperative

    Patient health questionnaire 9 (PHQ-9) score

  12. Change in quality of life

    Time frame: Up to 6 months postoperative

    EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36

  13. Change in health-related function

    Time frame: Up to 6 months postoperative

    EQ-5D-5L, RAND-36

  14. Change in osteoarthritis-related symptoms

    Time frame: Up to 12 months postoperative

    WOMAC OA

Other outcomes

  1. Change in physical activity

    Time frame: Up to 6 months postoperative

    International physical activity questionnaire short form (IPAQ-sf)

  2. Change in pain catastrophizing

    Time frame: Up to 6 months postoperative

    Pain catastrophizing scale (PCS)

  3. Change in kinesiophobia

    Time frame: Up to 6 months postoperative

    Tampa scale of kinesiophobia (TSK)

  4. Change in subjective pain sensitivity

    Time frame: Up to 6 months postoperative

    Pain sensitivity questionnaire (PSQ)

  5. Fibromyalgia severity score

    Time frame: Up to 6 months postoperative

    Sum of widespread pain index + symptom severity scale (ACR 2016)

  6. Pain-related acceptance

    Time frame: Up to 6 months postoperative

    Chronic pain acceptance questionnaire (CPAQ-8)

  7. Changes in blood biomarkers

    Time frame: Up to 6 months postoperative

    Inflammatory mediators, monoamine metabolites, coagulation system etc

Study contacts

Contact information is provided by the study sponsor or research team.

Martin F Bjurström, MD, PhD

CONTACT

[email protected]

+46739512728

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: PROSAP-A

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Nov 24, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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