Henry Ford Hospital
Detroit, Michigan, 48202, United States
NCT Number: NCT04896892
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Detroit, Michigan, 48202, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: One week preoperative to six months postoperative
Sleep patterns include total sleep duration, rapid eye movement sleep duration, deep sleep duration, light sleep duration, number of awakening during the night, and time to fall asleep. This measurement will be completed by all study patients.
Time frame: 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
Measurement of the patient's pain through self-assessment scoring. This measurement will be completed by all study patients.
Time frame: The first measurement will be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.
The PROMIS survey is filled out by the patient and assesses patient mental, physicial, and social health. This measurement will be completed by all study patients.
Time frame: 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.
The PSQI is filled out by the patient and assesses patient sleep quality. This measurement will be completed by all study patients.
Time frame: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.
The HOOS is filled out by the patient and assesses the patients feeling regarding their hip function and abilities. This measurement will only be assessed in patients undergoing total hip arthroplasty.
Time frame: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.
The KOOS is filled out by the patient and assesses the patients feeling regarding their knee function and abilities. This measurement will only be assessed in patients undergoing total knee arthroplasty.
Contact information is provided by the study sponsor or research team.
Henry Ford Health System
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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