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NCT Number: NCT04896892

Sleep Patterns After Total Joint Replacement Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sleep Patterns

    Time frame: One week preoperative to six months postoperative

    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.

Secondary outcomes

  1. Visual Analog Pain

    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 visit

    Measurement of the patient's pain through self-assessment scoring. This measurement will be completed by all study patients.

  2. Patient Reported Outcomes Measure Information System

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

    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.

  3. Pittsburgh Sleep Quality Index

    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.

    The PSQI is filled out by the patient and assesses patient sleep quality. This measurement will be completed by all study patients.

  4. Hip Disability and Osteoarthritis Outcome Score for Joint Replacement

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

    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.

  5. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

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

    The KOOS is filled out by the patient and assesses the patients feeling regarding their knee function and abilities. This measurement will only be assessed in patients undergoing total knee arthroplasty.

Study contacts

Contact information is provided by the study sponsor or research team.

Luke Wesemann

CONTACT

[email protected]

801-499-1859

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Consumer Sleep Solutions

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 21, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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