Sleep Patterns After Total Joint Replacement Surgery

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT04896892
Status
Not Yet Recruiting

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Conditions

  • Arthroplasty, Replacement, Hip
  • Arthroplasty, Replacement, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2025
Primary completion
Dec 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Total Knee Arthroplasty
    Patients in this group will be undergoing total knee arthroplasty.
  • Arm: Total Hip Arthroplasty
    Patients in this group will be undergoing total hip arthroplasty.

Primary Outcome Measure

Sleep Patterns [ Time Frame: One week preoperative to six months postoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202
Luke Wesemann
[email protected]
801-499-1859

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By research site
Henry Ford Hospital· Detroit, MI

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