Promoting Sleep to Alleviate Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive behavioral therapy for insomnia (CBT-I)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Sleep education therapy (SET)

Intervention Type BEHAVIORAL

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

Interventions

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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)

Intervention Type BEHAVIORAL

Sleep education therapy (SET)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No