TKA Melatonin and Sleep Quality (NCT05332717) | Clinical Trial Compass
CompletedNot Applicable
TKA Melatonin and Sleep Quality
United States176 participantsStarted 2022-01-10
Plain-language summary
This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.
Who can participate
Age range
18 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:
* Patients undergoing primary, unilateral TKA
* Primary diagnosis of osteoarthritis (OA)
* Aged 18+
* Subject is opioid naive (has not taken opioids during the 6 months prior to surgery)
* Subject is not currently taking sleep medication
* English speaking
* Has working email (for survey purposes)
Exclusion Criteria:
* Patients with diagnosis other than OA including: Inflammatory arthritis; Post-traumatic OA; Chronic pain; Insomnia\*; Depression\*; Anxiety\*; Any active sleep disorder
* Planned contralateral knee or subsequent total joint arthroplasty within 90 days
* Any planned surgery within 90 days
* Patient taking medication for depression or insomnia or anxiety during the 6 months prior to surgery
* Patients with renal or hepatic disorders as these can affect melatonin metabolism
* Insomnia, anxiety, and depression will be defined as use of controlled medication for that disorder which will be identified in istop or HSS record of the patient filled in the 6 months prior to surgery
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.