drugset / Trial / NCT07598734

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

NCT07598734

Phase 4 Not yet recruiting 129 enrolled University of Washington
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2026-06
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxepin Unknown 6 mg Oral
Subject Ramelteon Unknown 8 mg Oral

Indications

No indication recorded.