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

Trial Summary

What is the purpose of this trial?

This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure.

Research Team

Helen Burgess, PhD

Principal Investigator

University of Michigan

Robert R Edwards, PhD

Principal Investigator

Brigham and Women's Hospital

Michael T Smith, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I have knee osteoarthritis.

I am 60 years old or older.

Have trouble falling or staying asleep

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

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

Treatment Details

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.

Participant Groups

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+