NCT06976138

Sleep TO Prevent Post-surgical Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This research is being done to evaluate whether combining Cognitive Behavioral Therapy for Insomnia (talk therapy for insomnia) with Morning Bright Light exposure is more effective than Morning Negative Ion exposure combined with either Cognitive Behavioral Therapy for Insomnia or Sleep / Knee Osteoarthritis Education to reduce pain following total knee replacement surgery. This knowledge is needed to develop better ways to manage pain after surgery. Sleep problems are often not treated before or after surgery, so this may differ from the typical care received by adding a focus on sleep. People with knee osteoarthritis, who are 60 years old and older, who are scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and who have trouble falling or staying asleep, may join this study. There are two possible devices that are being compared in this study. * If the participants are in the Morning Bright Light exposure group, the participants will use the Re-timer®, a wearable bright light exposure device. This device is commercially available and in use by the general population. This device meets international ultraviolet and blue light hazard safety standards. The light intensities used in this study are greater than most indoor light, but much dimmer than sunlight on a bright day. * If the participants are in the Negative Ionizer exposure group, the participants will use the IonPacific,"ionMi,"a wearable negative ionizer. This device is also commercially available and in use by the general population. There have been reports of improved sleep and daytime symptoms associated with poor sleep for both Morning Bright Light and Negative Ionizer exposures. The use of Re-timer and IonMi in this research study is investigational. The word "investigational" means that the Re-timer and IonMi are not approved for marketing by the Food and Drug Administration (FDA). Participation includes: A virtual and in person screening and training visit 4, 1-hour long telehealth sessions scheduled each week before surgery 2, 30-minute telehealth sessions, 2-weeks after surgery and 3-months after surgery This study will be using "blinding" which means only a few members of the study team will know what group / sleep program the participants have been assigned to until the study ends. In case of an emergency, the study doctor can quickly find out which sleep health program the participants have been assigned to receive. During parts of the study, the device the participants are using may be deactivated in order to test the effects of an active study device compared to a deactivated device. At the end of the study, the team can provide information about the timing of device deactivation. The participants will not be asked to change the clinical care currently being received for knee osteoarthritis.

Conditions

• Knee Osteoarthristis

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Therapy for Insomnia	This program will focus on changing the participant's sleep patterns, activities, and habits.
DEVICE	Bright Light therapy via the Re-Timer®	Subjects will conduct light treatment in the mornings at home for one hour using Re-timer® 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
DEVICE	Negative Ion exposure via IonMi Device	This procedure involves wearing a light weight negative ionizer (IonMi Device) around 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
BEHAVIORAL	Sleep / Knee Osteoarthritis Education	This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.

Timeline

• Start date: 2025-06-13
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2025-05-16
• Last updated: 2025-06-18

Locations

2 sites across 1 country: United States