Osteoarthritis, KneePROSAP-ANCT06145516
Promoting Sleep to Alleviate Pain - Arthroplasty
A study testing Cognitive behavioral therapy for insomnia (CBT-I) and Sleep education therapy (SET) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia (CBT-I) and Sleep education therapy (SET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Surgical Sciences, Uppsala University
Uppsala, Uppland, 75185
Andrea Niklasson, M.D., 0046186122110, andrea.niklasson@gmail.com
Martin F Bjurström, Associate Professor
About this study
Official title: Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications
- Being tested
- Cognitive behavioral therapy for insomnia (CBT-I), Sleep education therapy (SET)
- Keywords
- osteoarthritis, total knee arthroplasty, total hip arthroplasty, insomnia, sleep disturbance, postoperative pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Sleep Initiation and Maintenance Disorders, Pain, Postoperative, Postoperative Complications, Osteoarthritis, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomnia (CBT-I)Behavioural
Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)
Sleep education therapy (SET)Behavioural
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative. Receives: Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) |
| Sleep education therapy (SET) | Active comparator | The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative. Receives: Behavioral: Sleep education therapy (SET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain intensity
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Measured: First 7 postoperative days
Secondary outcomes (14)
Pre- and acute postoperative change in sleep measures from baseline
insomnia severity index, Pittsburgh sleep quality index, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency)
Measured: Up to 2 weeks postoperative
Acute postoperative opioid consumption
Oral morphine mg equivalents (OMEQs)
Measured: Postoperative day (POD) 1 and POD1-7
Recovery in the acute postoperative phase
Quality of recovery (QoR) 15 score
Measured: First 7 postoperative days
Long-term postoperative sleep quality
insomnia severity index
Measured: Up to 12 months postoperative
Postoperative objective sleep continuity
actigraphic sleep efficiency [SE]
Measured: Up to 6 months postoperative
Pain intensity 6 months postoperative
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Measured: 6 months postoperative
Change in pain measures from baseline
BPI pain severity and pain interference score, QoR-15 pain score, WOMAC OA pain score
Measured: Up to 12 months postoperative
Changes in quantitative sensory testing (QST) measures of pain
Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test
Measured: Up to 6 months postoperative
Change in cognitive function
Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions
Measured: Up to 6 months postoperative
Change in anxiety from baseline
Generalized anxiety disorder 7 (GAD-7) score
Measured: Up to 6 months postoperative
Change in depression from baseline
Patient health questionnaire 9 (PHQ-9) score
Measured: Up to 6 months postoperative
Change in quality of life
EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36
Measured: Up to 6 months postoperative
Change in health-related function
EQ-5D-5L, RAND-36
Measured: Up to 6 months postoperative
Change in osteoarthritis-related symptoms
WOMAC OA
Measured: Up to 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Sep 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin F Bjurström, MD, PhD, Principal investigator, Uppsala University / Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145516
- Sponsor's protocol ID
- Dnr 2023-03976-01
- Acronym
- PROSAP-A
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjurstrom MF, Bothelius K, Maathz P, Jernelov S, Kraepelien M, Rosenstrom AHC, Niklasson A, Smith MT, Olmstead R, Irwin MR, Finan PH, Kosek E. Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial. BMJ Open. 2025 Jul 30;15(7):e099785. doi: 10.1136/bmjopen-2025-099785.
PubMed 40738630
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06145516
- Acronym / sponsor ID
- PROSAP-A / Dnr 2023-03976-01
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications
- Keywords
- osteoarthritis, total knee arthroplasty, total hip arthroplasty, insomnia, sleep disturbance, postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative. |
| Sleep education therapy (SET) | Active comparator | Behavioral: Sleep education therapy (SET)The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Cognitive behavioral therapy for insomnia (CBT-I) |
| Sleep education therapy (SET)Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse | Behavioural | Sleep education therapy (SET) |
Primary outcome
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
14 secondary outcomes
Pre- and acute postoperative change in sleep measures from baseline
Time frame: Up to 2 weeks postoperative
Acute postoperative opioid consumption
Time frame: Postoperative day (POD) 1 and POD1-7
Recovery in the acute postoperative phase
Time frame: First 7 postoperative days
Long-term postoperative sleep quality
Time frame: Up to 12 months postoperative
Postoperative objective sleep continuity
Time frame: Up to 6 months postoperative
Pain intensity 6 months postoperative
Time frame: 6 months postoperative
Change in pain measures from baseline
Time frame: Up to 12 months postoperative
Changes in quantitative sensory testing (QST) measures of pain
Time frame: Up to 6 months postoperative
Change in cognitive function
Time frame: Up to 6 months postoperative
Change in anxiety from baseline
Time frame: Up to 6 months postoperative
Change in depression from baseline
Time frame: Up to 6 months postoperative
Change in quality of life
Time frame: Up to 6 months postoperative
Change in health-related function
Time frame: Up to 6 months postoperative
Change in osteoarthritis-related symptoms
Time frame: Up to 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40738630Bjurstrom MF, Bothelius K, Maathz P, Jernelov S, Kraepelien M, Rosenstrom AHC, Niklasson A, Smith MT, Olmstead R, Irwin MR, Finan PH, Kosek E. Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial. BMJ Open. 2025 Jul 30;15(7):e099785. doi: 10.1136/bmjopen-2025-099785.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin F Bjurström, MD, PhD principal investigator
Uppsala University / Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia (CBT-I) and Sleep education therapy (SET) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin F Bjurström, MD, PhD (+46739512728, martin.flores.bjurstrom@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain intensity (time frame: First 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.