Clinical trial NCT04896892: Sleep Patterns After Total Joint Replacement Surgery
Official title: Sleep Patterns After Total Joint Replacement Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Consumer Sleep Solutions
First posted: 2021-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients over the age of 18 who are scheduled to receive total hip arthroplasty or total knee arthroplasty.

Brief summary: 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: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sleep Patterns
timeFrame: One week preoperative to six months postoperative
Secondary outcomes:
measure: Visual Analog Pain
timeFrame: 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
measure: Patient Reported Outcomes Measure Information System
timeFrame: The first measurement will be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.
measure: Pittsburgh Sleep Quality Index
timeFrame: 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.
measure: Hip Disability and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Michael Charters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.