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Sleep Patterns After Total Joint Replacement Surgery

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Henry Ford Health

Status

Not yet enrolling

Conditions

Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee

Study type

Observational

Funder types

Other

Identifiers

NCT04896892
13680 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Luke Wesemann

Data sourced from clinicaltrials.gov

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