Sleep Interventions for Postoperative Pain
(STOPPP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore ways to improve sleep issues before knee replacement surgery through various treatments. Participants will either undergo Cognitive Behavioral Therapy for Insomnia, a program designed to change sleep patterns and habits, or receive light exposure therapy. Some participants might also experience negative ion exposure, where a device releases negatively charged ions into the air. People over 60 with knee osteoarthritis, scheduled for knee surgery, and experiencing sleep difficulties might be a good fit for this study.
As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance sleep and recovery outcomes for future patients.
Will I have to stop taking my current medications?
If you are currently using medications to help with sleep or over-the-counter sleep aids like melatonin, you will need to stop taking them at least 2 weeks before joining the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What prior data suggests that these methods for addressing sleep problems are safe?
Research has shown that Cognitive-Behavioral Therapy for Insomnia (CBT-I) safely treats sleep problems. It is as effective as sleep medications but lacks side effects. Users of CBT-I often experience ongoing improvements in their sleep. Some may feel slightly sleepy during the day, but this typically resolves quickly.
Negative ion exposure involves wearing a device that releases negatively charged ions into the air. It is generally safe, though some individuals might initially feel a little dizzy or uncomfortable.
Morning bright light exposure requires wearing glasses that emit bright light for an hour each morning. This method has been safely used in other treatments, such as for seasonal affective disorder, a type of depression related to seasonal changes. Most people tolerate it well, though a few might initially experience eye strain or headaches.
Overall, these treatments are considered safe and well-tolerated by most individuals.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they combine Cognitive-Behavioral Therapy for Insomnia (CBT-I) with innovative interventions like negative ion exposure and morning bright light. Unlike standard post-surgery pain management, which often relies on medications, these approaches aim to improve sleep quality and potentially reduce pain through non-pharmaceutical means. Negative ion exposure uses a wearable device to release negatively charged ions, which may enhance mood and sleep. Meanwhile, the morning bright light therapy involves wearing special glasses that emit bright light, potentially resetting the body's internal clock and improving sleep patterns. These unique features offer a promising, drug-free alternative to managing postoperative pain and sleep disturbances.
What evidence suggests that this trial's treatments could be effective for postoperative pain?
Research shows that Cognitive-Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can improve sleep and reduce insomnia symptoms in people with pain. One study found that participants slept significantly better, with improvements lasting up to a year. In this trial, some participants will also receive negative ion exposure, which evidence suggests can help with mood disorders, though its impact on sleep remains uncertain. Another group will receive morning bright light exposure, known to improve sleep quality and potentially reduce confusion after surgery. Together, these treatments show promise in enhancing sleep and possibly easing post-surgical pain.678910
Who Is on the Research Team?
Robert R Edwards, PhD
Principal Investigator
Brigham and Women's Hospital
Michael T Smith, PhD
Principal Investigator
Johns Hopkins University
Helen Burgess, PhD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for individuals with knee arthritis who are scheduled for total knee replacement surgery and suffer from sleep problems. Specific eligibility details are not provided, but typically participants must meet certain health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Treatment
Participants receive Cognitive Behavioral Therapy and either Morning Bright Light or Negative Ion exposure for sleep improvement
Post-surgery Treatment
Continuation of Cognitive Behavioral Therapy and either Morning Bright Light or Negative Ion exposure
Follow-up
Participants are monitored for pain, sleep, and physical functioning post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive-Behavioral Therapy for Insomnia
Trial Overview
The study compares different pre-surgery sleep improvement methods: Bright Light therapy using Re-Timer®, Cognitive-Behavioral Therapy for Insomnia, Sleep/Knee Osteoarthritis Education, and Negative Ion exposure via the IonMi Device.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Morning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on/off times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. the participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Sleep / Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
Cognitive Behavioral Therapy for Insomnia in Pain ...
Main outcomes and measures: The primary outcome was change in mean pain intensity (assessed with Brief Pain Inventory [BPI]) at 12 months after ...
Cognitive Behavioral Therapy for Insomnia in Pain ...
CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity, sleep quality, beliefs about sleep, ...
Does Chronic Pain Affect the Efficacy of Cognitive ...
CBT-I improved validated measures of insomnia symptoms, sleep quality, fatigue, and sleepiness for as long as 12 months post-treatment.
Cognitive behavioral therapy for insomnia in patients with ...
Using global measures of sleep, we found a probability of 81% and 71% for having better sleep after CBT-I at post-treatment and final follow-up, respectively.
main outcomes of a randomized dismantling trial
All groups exhibited insomnia symptom reduction at posttreatment (CT: d = −2.53, P < .001; BT: d = −2.39, P < .001; CBT: d = −2.90, P < .001) ...
Cognitive-Behavioral Therapy for Insomnia: An Effective ...
CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...
7.
trialsjournal.biomedcentral.com
trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09013-3Digitally delivered cognitive behavioral therapy for insomnia ...
Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe treatment for insomnia [8, 9] and is recommended as first-line ...
Cognitive Behavioral Therapy for Insomnia With Prolonged ...
This study compared the efficacy of integrated cognitive behavioral therapy for insomnia (CBT-I) and prolonged exposure (PE; CBTI-PE) therapy to ...
a focus on components of cognitive behavioral therapy for ...
It is a safe therapy with lasting effects and only transient initial side effects such as daytime drowsiness or fatigue [8]. Despite its ...
Effects of cognitive behavioral therapy for insomnia (CBT-I) ...
CBT-I has previously been shown to be an effective intervention for insomnia, and the current systematic review indicates a potential but small effect on QoL.
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