Sleep TO Prevent Post-surgical Pain (NCT06976138) | Clinical Trial Compass
RecruitingNot Applicable
Sleep TO Prevent Post-surgical Pain
United States252 participantsStarted 2025-06-13
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index