Knee Osteoarthristis
Conditions
Keywords
total knee arthroplasty, knee replacement, koa, knee osteoarthritis
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.
Interventions
This program will focus on changing the participant's sleep patterns, activities, and habits.
DEVICEBright 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
DEVICENegative 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
BEHAVIORALSleep / Knee Osteoarthritis Education
This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only the interventionist and biostatistician will have access to group assignment
Intervention model description
randomized controlled, 3-parallel arm, trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index | 3 and 6 months post-surgery | Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity | immediately post surgery, 6 weeks post surgery | Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale. |
| Number of participants with Post-surgical opioid use | 6-weeks post-surgery, 3 and 6 months post surgery | Opioid use after surgery reported in 7-day virtual diaries. Higher amounts mean higher intake of opioids. Participants will be asked to report prescribed opioids, how often being taken, and provide information via virtual pill count. |
| Insomnia Severity as assessed by the Insomnia Severity Index | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months | Minimum score possible is 0, highest score 28. Higher scores indicate higher insomnia symptoms |
| Circadian Rest Activity Rhythm (RAR) assessed by actigraphy | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months | Motion data from actigraphy monitors will be used to estimate circadian rest activities within and across 24-hour intervals. The investigators will model standard circadian RAR parameters derived from actigraphy data using both an extended cosinor analysis as well as non-parametric methods. For example, Pseudo F-statistics, and index of circadian rest activity rhythm, will be derived, and lower Pseudo F-statistics are related to less robust rest activity rhythm strength |
| Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9) | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months | Score range of 0-27. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wake After Sleep Onset Time (minutes) as assessed by actigraphy | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months | Motion information from actigraphy monitors will be used with sleep diaries to provide information about sleep continuity patterns. This measure will use 1-week averages to determine wake after sleep time. |
| Total Sleep Time (minutes) as assessed by actigraphy | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months | Motion information from actigraphy monitors will be used with sleep diaries to provide information about sleep continuity patterns. This measure will use 1-week averages to determine total sleep time. |
| Sleep Onset Latency (minutes) as assessed by actigraphy | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months | Motion information from actigraphy monitors will be used with sleep diaries to provide information about sleep continuity patterns. This measure will use 1-week averages to determine sleep onset latency. |
| Sleep Efficiency as assessed by actigraphy | pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months | Motion information from actigraphy monitors will be used with sleep diaries to provide information about sleep continuity patterns. This measure will use 1-week averages to determine sleep efficiency. |
| Post-surgical Physical Functioning as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Functioning | 3 and 6 months post-surgery | Higher scores indicate greater issues with physical functioning. Asked to rate difficulty performing different tasks from 0 (no difficulty) to 10 (extreme difficulty). Score range 0-68. |
Countries
United States
Contacts
Primary ContactAnna Kim-Dahl
Backup ContactMarise Owens
Outcome results
None listed