Sleep Patterns After Total Joint Replacement Surgery

NCT04896892 | Not Yet Recruiting

• 1 other identifier: 13680
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Outcome Measures

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.

  One week preoperative to six months postoperative

Secondary Outcomes (5)

• Visual Analog Pain

  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

  The first measurement will be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.

• Pittsburgh Sleep Quality Index

  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

  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

  The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.

Study Arms (2)

Total Knee Arthroplasty

Patients in this group will be undergoing total knee arthroplasty.

Total Hip Arthroplasty

Patients in this group will be undergoing total hip arthroplasty.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Consumer Sleep Solutions: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Michael Charters, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Wesemann

CONTACT

801-499-1859; lwesema1@hfhs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)