Sleep Interventions for Postoperative Pain

(STOPPP Trial)

Recruiting at 1 trial location

Overseen By Anna Kim-Dahl

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Sleep aids, Photosensitizing drugs

Disqualifiers: Rheumatologic, Seizure, Bipolar, Substance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

252 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Have trouble falling or staying asleep

I have knee osteoarthritis.

I am 60 years old or older.

Exclusion Criteria

Have a serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder

Are pregnant or lactating

I have an eye condition affecting my retina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

A virtual and in-person screening and training visit

Pre-surgery Treatment

Participants receive Cognitive Behavioral Therapy and either Morning Bright Light or Negative Ion exposure for sleep improvement

4 weeks

4, 1-hour long telehealth sessions scheduled each week before surgery

Post-surgery Treatment

Continuation of Cognitive Behavioral Therapy and either Morning Bright Light or Negative Ion exposure

4 weeks

2, 30-minute telehealth sessions, 2-weeks after surgery

Follow-up

Participants are monitored for pain, sleep, and physical functioning post-surgery

6 months

2, 30-minute telehealth sessions, 3-months after 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?

Group I: Cognitive Behavioral Therapy + Morning Bright Light exposure Experimental Treatment 2 Interventions

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.

Group II: Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure Active Control 2 Interventions

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.

Group III: Sleep / Knee Osteoarthritis Education + Negative Ion exposure Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39120902/

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 ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822153

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, ...

3. jwatch.org jwatch.org/na57848/2024/08/22/does-chronic-pain-affect-efficacy-cognitive-behavioral

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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079221000459

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.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

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) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

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/s13063-025-09013-3

Digitally 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 ...

8. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1649937.pdf

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 ...

9. kosinmedj.org kosinmedj.org/journal/view.php?number=1311

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 ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

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.