Sleep Patterns After Total Joint Replacement Surgery

May 6, 2024 updated by: Michael Charters, MD, Henry Ford Health System
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week preoperative to six months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
The first measurement will be taken one week preoperatively. Postoperative measurements occur at three weeks and three months.
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.
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
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.
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
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.
The first measurement will occur one week preoperatively. Postoperative measurements occur at three weeks and three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Consumer Sleep Solutions

Investigators

  • Principal Investigator: Michael Charters, MD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 13680 (Stanford IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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