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NOT YET RECRUITING
NCT07598734
PHASE4

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

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. This study aims to determine whether the medications doxepin, either alone or in combination with ramelteon, can improve sleep quality during early recovery after TKA. The investigators will also evaluate whether improved sleep leads to better pain control, knee function, and overall quality of life.

Official title: Doxepin Versus Doxepin and Ramelteon Versus Placebo to Improve Sleep Quality After Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2026-06

Completion Date

2028-06

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

Doxepin 6 mg

Doxepin 6 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty

DRUG

Ramelteon 8 mg

Ramelteon 8 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty

DRUG

Placebo Tablets

Placebo administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty

Locations (1)

University of Washington Medical Center Hip & Knee Center

Seattle, Washington, United States