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

Conditions

• Postoperative Knee Function
• Quality of Life After Primary TKA
• Sleep Quality Post-TKA

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Doxepin 6 mg — DRUG
  Doxepin 6 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty
• Ramelteon 8 mg — DRUG
  Ramelteon 8 mg administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty
• Placebo Tablets — DRUG
  Placebo administered orally once nightly for sleep during the first 6 weeks of the postoperative period following total knee arthroplasty

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

129 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Doxepin 6 mg
  Participants receive doxepin 6 mg and matching placebo orally once nightly for sleep during the first 6 weeks postoperative period following total knee arthroplasty.
• Experimental: Doxepin 6 mg and Ramelteon 8mg
  Participants receive doxepin 6 mg and ramelteon 8 mg orally once nightly for sleep during the first 6 weeks postoperative period following total knee arthroplasty.
• Placebo Comparator: Placebo
  Participants receive 2 matching placebos orally once nightly for sleep during the first 6 weeks postoperative period following total knee arthroplasty.

Primary Outcome Measure

Insomnia Severity Index (ISI) scores (sleep quality) [ Time Frame: Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively ]

Central Contacts

• Gerald Y Liao, MS
  617-710-7211
  [email protected]
• Nicholas M Hernandez, MD
  530-514-1275
  [email protected]

Locations (1)

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