Clinical trial NCT06976138: Sleep TO Prevent Post-surgical Pain
Official title: Sleep TO Prevent Post-surgical Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: total knee arthroplasty
knee replacement
koa
knee osteoarthritis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-16
Enrollment: 252
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled, 3-parallel arm, trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 3 and 6 months post-surgery
Secondary outcomes:
measure: Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity
timeFrame: immediately post surgery, 6 weeks post surgery
measure: Number of participants with Post-surgical opioid use
timeFrame: 6-weeks post-surgery, 3 and 6 months post surgery
measure: Insomnia Severity as assessed by the Insomnia Severity Index
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
measure: Circadian Rest Activity Rhythm (RAR) assessed by actigraphy
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
measure: Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Other outcomes:
measure: Post-surgical Physical Functioning as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Functioning
timeFrame: 3 and 6 months post-surgery
measure: Wake After Sleep Onset Time (minutes) as assessed by actigraphy
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
measure: Total Sleep Time (minutes) as assessed by actigraphy
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
measure: Sleep Onset Latency (minutes) as assessed by actigraphy
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
measure: Sleep Efficiency as assessed by actigraphy
timeFrame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Chestnut Hill
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Michael T Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Helen Burgess, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Robert R Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: