Меню
Набор скоро начнётся NCT07598734

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

Фаза IV С лечением Sleep Quality Post-TKA Postoperative Knee Function Quality of Life After Primary TKA

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Doxepin 6 mg, Ramelteon 8 mg, Placebo Tablets.
Кому может быть актуально
Состояния в реестре: Sleep Quality Post-TKA, Postoperative Knee Function, Quality of Life After Primary TKA. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • Those receiving primary total knee arthroplasty (TKA)
  • 80 years or less, age 18 or greater

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Washington Medical Center Hip & Knee Center — Seattle

Идентификаторы

NCT: NCT07598734 · STUDY00024373

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗