Sleep TO Prevent Post-surgical Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 4
- 主要终点
- Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Only the interventionist and biostatistician will have access to group assignment
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Behavioral Therapy + Morning Bright Light exposure
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.
干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy + Morning Bright Light exposure
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.
干预措施: Bright Light therapy via the Re-Timer® (Device)
Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure
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.
干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure
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.
干预措施: Negative Ion exposure via IonMi Device (Device)
Sleep / Knee Osteoarthritis Education + Negative Ion exposure
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.
干预措施: Negative Ion exposure via IonMi Device (Device)
Sleep / Knee Osteoarthritis Education + Negative Ion exposure
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.
干预措施: Sleep / Knee Osteoarthritis Education (Behavioral)
结局指标
主要结局
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 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.
次要结局
- Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity(immediately post surgery, 6 weeks post surgery)
- Number of participants with Post-surgical opioid use(6-weeks post-surgery, 3 and 6 months post surgery)
- Insomnia Severity as assessed by the Insomnia Severity Index(pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months)
- Circadian Rest Activity Rhythm (RAR) assessed by actigraphy(pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months)
- Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9)(pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months)