Sleep treatments before knee replacement for people with knee osteoarthritis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 60 or older with knee osteoarthritis who have trouble falling or staying asleep. They must be scheduled for a total replacement of one knee.

Age

60 years and older

Sex

All sexes

Disease stage

Knee osteoarthritis, with a planned total replacement of one knee because of osteoarthritis. People must also have trouble falling or staying asleep.

Earlier treatment

People cannot join if they now take sleep medicines or have finished Cognitive Behavioral Therapy for Insomnia. They also cannot join if they used Bright Light or Negative Ion exposure in the past year. People must stop over-the-counter sleep aids (for example, melatonin) for at least 2 weeks before joining.

Main reasons for not taking part

• Inflammatory rheumatic disease, seizure disorder, or taking disease-modifying antirheumatic drugs
• Serious mental health disorder, Bipolar I disorder, or substance or alcohol use disorder
• Serious sleep or body-clock disorder, or untreated sleep apnea
• Pregnant or breastfeeding
• Retina disease, past eye surgery (Lasik or cataract okay if more than 3 months ago), or taking medicines that make you sensitive to light

The registry criteria, word for word

What the trial wants to find out

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.

The 3 groups in the trial

• Cognitive Behavioral Therapy + Morning Bright Light exposureTreatment being tested

  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: Cognitive-Behavioral Therapy for Insomnia and Bright Light therapy via the Re-Timer®

• Cognitive Behavioral Therapy for Insomnia + Negative Ion exposureExisting treatment, for comparison

  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: Cognitive-Behavioral Therapy for Insomnia and Negative Ion exposure via IonMi Device

• Sleep / Knee Osteoarthritis Education + Negative Ion exposureExisting treatment, for comparison

  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: Negative Ion exposure via IonMi Device and Sleep / Knee Osteoarthritis Education