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Not yet recruiting NCT07598734

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

Phase IV Interventional Sleep Quality Post-TKA Postoperative Knee Function Quality of Life After Primary TKA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxepin 6 mg, Ramelteon 8 mg, Placebo Tablets.
Who it may be relevant to
Registry conditions: Sleep Quality Post-TKA, Postoperative Knee Function, Quality of Life After Primary TKA. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This randomized, placebo-controlled clinical trial seeks to answer the following question: Is doxepin or combination therapy consisting of doxepin plus ramelteon superior to placebo in terms of (1) sleep quality as measured by the Insomnia Severity Index, (2) postoperative knee function as measured by KOOS-JR, KOOS-PS, or (3) overall health-related quality of life during the first three months after total knee arthroplasty.

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

Primary outcome measures

  • Insomnia Severity Index (ISI) scores (sleep quality) [Time frame: Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively]
Secondary outcome measures (3)
  • Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS) [Time frame: Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively.]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) [Time frame: Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively]
  • Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) [Time frame: Baseline; 2 weeks postoperatively; 6 weeks postoperatively; 3 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Washington Medical Center Hip & Knee Center — Seattle

Identifiers

NCT: NCT07598734 · STUDY00024373

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗