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Набор скоро начнётся NCT04896892

Sleep Patterns After Total Joint Replacement Surgery

— Наблюдательное Arthroplasty, Replacement, Knee Arthroplasty, Replacement, Hip

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip. Базовые параметры: от 18 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 →

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Обзор

The purpose of this study is to determine sleep patterns and sleep quality following total joint arthroplasty, in order to understand when patients should expect to return to baseline or improved sleep following total joint arthroplasty. Patients prospectively enrolled in this study are to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA). Patients will receive the SleepScore Max device and smart device app to track their sleep patterns starting one week prior to surgery and until six months after surgery. The SleepScore Max device tracks duration of sleep, time to fall asleep, number of nightly awakenings, rapid eye movement sleep, light sleep, deep sleep, and room temperature and light levels. Through the associated application, patients will also record caffeine and alcohol consumption and exercise. In addition to sleep tracking, patients will fill out Pittsburgh Sleep Quality Index (PSQI), PROMIS, Hip Disability and Osteoarthritis Outcome Score (HOOS), and Knee Injury and Osteoarthritis Outcome Score (KOOS) surveys at specified visits. Secondarily, Visual Analog Pain (VAP) scores and opioid consumption measure in milligram morphine equivalents (MME) will be measured during hospital stay and at subsequent post-operative clinic visits. The clinical goal of this study is to better under sleep patterns in patients undergoing TKA and THA and hopefully provide this patient population improved sleep recommendations and interventions.

Первичные конечные точки

  • Sleep Patterns [Срок оценки: One week preoperative to six months postoperative]
Вторичные конечные точки (5)
  • Visual Analog Pain [Срок оценки: Measurements will occur one week preoperatively, during the postoperative hospital stay, and at each subsequent postoperative visit, which include a three week and twelve week visit]
  • Patient Reported Outcomes Measure Information System [Срок оценки: The first measurement will be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.]
  • Pittsburgh Sleep Quality Index [Срок оценки: The first measurement will occur one week preoperatively. Postoperative measurements occur at the following time points: one week, three weeks, five weeks, seven weeks, nine weeks, three months, four months, five months, and six months.]
  • Hip Disability and Osteoarthritis Outcome Score for Joint Replacement [Срок оценки: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.]
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [Срок оценки: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.]

Критерии участия

Критерии включения

  • Patient is to undergo ambulatory total hip arthroplasty or total hip knee arthroplasty.
  • Patient is 18 years or older.

Критерии исключения

  • Patient is unable to give consent
  • Non-English speaking patients
  • Patients with pre-existing sleep disorders or neurological disorders, including dementia.
  • Patients taking hypnotic drugs or other medication that is known to affect sleep.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Henry Ford Hospital — Detroit

Публикации

  • Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available. PMID 8652329
  • Hinz A, Glaesmer H, Brahler E, Loffler M, Engel C, Enzenbach C, Hegerl U, Sander C. Sleep quality in the general population: psychometric properties of the Pittsburgh Sleep Quality Index, derived from a German community sample of 9284 people. Sleep Med. 2017 Feb;30:57-63. doi: 10.1016/j.sleep.2016.03.008. Epub 2016 May 4. PMID 28215264
  • Knill RL, Moote CA, Skinner MI, Rose EA. Anesthesia with abdominal surgery leads to intense REM sleep during the first postoperative week. Anesthesiology. 1990 Jul;73(1):52-61. doi: 10.1097/00000542-199007000-00009. PMID 2360740

Идентификаторы

NCT: NCT04896892 · 13680

Первоисточники (государственные реестры)

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