New study tests sleep pills to boost knee surgery recovery
NCT ID NCT07598734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the sleep aids doxepin and ramelteon can improve sleep quality during the first 6 weeks after total knee replacement. About 129 adults will be randomly assigned to take doxepin alone, doxepin plus ramelteon, or a placebo pill each night. The goal is to see if better sleep leads to less pain, better knee function, and improved quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxepin and ramelteon
- What this could lead to
- If it works, this could provide a safe, effective option to improve sleep and recovery after knee replacement surgery.
- What could go wrong
- This is a small, early-phase trial (129 people) testing drugs for a short period. Results may not apply to everyone, and side effects or lack of benefit are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 129 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Those receiving primary total knee arthroplasty (TKA) * 80 years or less, age 18 or greater Exclusion Criteria: * History of cardiovascular bundle branch block * Actively taking selecrtive serotoin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or having treatment via counseling/psychotherapy for major depression or anxiety, bipolar, or psychotic disorder * Pre-operative narcotics (defined as more than 1 prescription in the past 3 months) * Self-reported use of alcohol in excess of \>2 drinks/day (in men) and \> 1 drink/day (in women) * Use of prescription sleep aids (e.g., Ambien, Trazadone) prior to surgery (i.e., melatonin or other OTC sleep aids are permitted) * History of major sleep disorder (e.g., obstructive sleep apnea (OSA), restless leg syndrome, narcolepsy) * Pregnant, breastfeeding or planning to become pregnant in the next 3 months post-surgery. No pregnancy testing will be performed; screening will rely solely on participant self-report. * Unable to take the study medication(s) due to contraindications with other medications the patient uses * Have been diagnosed with (or are at risk of) narrow-angle or angle-closure glaucoma. In order to be eligible, participants must be able to report that they have had their eyes dilated within the past year without problems. * Have severe urinary retention or difficulty emptying your bladder. * Had glaucoma-related eye procedures (e.g., laser iridotomy) * Ongoing use of glaucoma eye drops.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Postoperative knee function are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Washington Medical Center Hip & Knee Center
Seattle, Washington, 98133, United States