Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty

{ "Doxepin and Ramelteon for Sleep After Total Knee Replacement", "This study is looking at ways to improve sleep after total knee replacement surgery (TKA). Many people have trouble sleeping during recovery, which can make pain worse and slow healing. This trial will test if the medications doxepin, or doxepin combined with ramelteon, can help you sleep better during the first six weeks after surgery. Researchers will compare these medications to a placebo (an inactive pill). They also want to see if better sleep leads to less pain, better knee function, and an improved quality of life. You may be able to join if you are between 18 and 80 years old and are having a primary total knee replacement.", "design": "This is a randomized, placebo-controlled study planning to enroll 129 participants. Participants will be assigned by chance to receive doxepin, doxepin combined with ramelteon, or a placebo.", "commitments": "Participants will take medication nightly for six weeks after surgery. Sleep quality, knee function, and quality of life will be measured at baseline, 2 weeks, 6 weeks, and 3 months post-surgery.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for three months after their total knee replacement surgery.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty

Not Yet Recruiting

PHASE4Ages 18–80InterventionalSupportive care

University of Washington

~129 participants

Updated 2026-05-20 on ClinicalTrials.gov

What's tested:Doxepin 6 mgRamelteon 8 mgPlacebo Tablets

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Insomnia Severity Index (ISI) scores (sleep quality)

Measured over Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively

Conditions

Sleep Quality Post-TKA

Postoperative Knee Function

Quality of Life After Primary TKA

Where it's being run

1 sites across 1 states

Washington1

Study leadership

Nicholas M Hernandez, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Gerald Y Liao, MS

[email protected]

617-710-7211

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Those receiving primary total knee arthroplasty (TKA)

80 years or less, age 18 or greater

Exclusion

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.

What this trial measures

Insomnia Severity Index (ISI) scores (sleep quality)Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively
Insomnia Severity Index (ISI) The Insomnia Severity Index is a 7-item self-reported questionnaire assessing the nature, severity, and impact of insomnia. * Score range: 0 to 28 * Interpretation: Higher scores indicate worse insomnia severity Score categories: * 0-7: No clinically significant insomnia * 8-14: Subthreshold insomnia * 15-21: Clinical insomnia (moderate severity) * 22-28: Clinical insomnia (severe)

Trialytics