Sleep TO Prevent Post-surgical Pain (STOPPP)

Johns Hopkins University

Status: Not yet enrolling

Conditions: Knee Osteoarthristis

Treatments: Device: Negative Ion exposure via IonMi Device; Behavioral: Cognitive-Behavioral Therapy for Insomnia; Behavioral: Sleep / Knee Osteoarthritis Education; Device: Bright Light therapy via the Re-Timer®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06976138

IRB00454253

1R01AG085712-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People with knee osteoarthritis,
• 60 years old and older,
• scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
• have trouble falling or staying asleep

Exclusion criteria

• currently using medications to help sleep
• have completed Cognitive Behavioral Therapy for Insomnia
• used either Bright Light or Negative Ion exposures in the past year
• have an inflammatory rheumatologic disorder, seizure disorder
• serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
• serious sleep or circadian rhythm disorder, untreated sleep apnea
• are pregnant or lactating
• have retinal pathology
• history of eye surgery (Lasik or cataract okay if more than 3 months ago)
• are taking disease-modifying antirheumatic drugs
• taking photosensitizing medications
• are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 3 patient groups

Cognitive Behavioral Therapy + Morning Bright Light exposure

Experimental group

Description:

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.

Treatment:

Device: Bright Light therapy via the Re-Timer®

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Device: Negative Ion exposure via IonMi Device

Sleep / Knee Osteoarthritis Education + Negative Ion exposure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep / Knee Osteoarthritis Education

Device: Negative Ion exposure via IonMi Device