Sleep TO Prevent Post-surgical Pain
ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJohns Hopkins University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy for Insomnia
BehavioralThis program will focus on changing the participant's sleep patterns, activities, and habits.
Bright Light therapy via the Re-Timer®
DeviceSubjects 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
Negative Ion exposure via IonMi Device
DeviceThis 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
Sleep / Knee Osteoarthritis Education
BehavioralThis program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
Treatment groups
252 Participants
are divided into 3 treatment groupsGroup A: Cognitive Behavioral Therapy + Morning Bright Light exposureExperimental treatment 2 interventions
Group B: Cognitive Behavioral Therapy for Insomnia + Negative Ion exposureActive comparator 2 interventions
Group C: Sleep / Knee Osteoarthritis Education + Negative Ion exposureActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
Time frame
3 and 6 months post-surgerySecondary outcomes
1
Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
Time frame
immediately post surgery, 6 weeks post surgery2
Number of participants with Post-surgical opioid use
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.
Time frame
6-weeks post-surgery, 3 and 6 months post surgery3
Insomnia Severity as assessed by the Insomnia Severity Index
Minimum score possible is 0, highest score 28. Higher scores indicate higher insomnia symptoms
Time frame
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months4
Circadian Rest Activity Rhythm (RAR) assessed by actigraphy
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
Time frame
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-monthsOther outcomes
1
Post-surgical Physical Functioning as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Physical Functioning
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.
Time frame
3 and 6 months post-surgery2
Wake After Sleep Onset Time (minutes) as assessed by actigraphy
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.
Time frame
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months3
Total Sleep Time (minutes) as assessed by actigraphy
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.
Time frame
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months4
Sleep Onset Latency (minutes) as assessed by actigraphy
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.
Time frame
pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov