Sleep Patterns After Total Joint Replacement Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient is to undergo ambulatory total hip arthroplasty or total hip knee arthroplasty.
Patient is 18 years or older.
Disqualifiers
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.
Trial population
The study population is patients over the age of 18 who are scheduled to receive total hip arthroplasty or total knee arthroplasty.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Total Knee Arthroplasty
Group B: Total Hip Arthroplasty
Trial outcomes
Primary outcomes
1
Sleep Patterns
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
One week preoperative to six months postoperativeSecondary outcomes
1
Visual Analog Pain
Measurement of the patient's pain through self-assessment scoring. 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 visit2
Patient Reported Outcomes Measure Information System
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 be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.3
Pittsburgh Sleep Quality Index
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 the following time points: one week, three weeks, five weeks, seven weeks, nine weeks, three months, four months, five months, and six months.4
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry Ford Health System
Lead sponsor
Consumer Sleep Solutions
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: