Sleep Patterns After Total Joint Replacement Surgery

NCT ID: NCT04896892

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Arthroplasty, Replacement, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total Knee Arthroplasty

Patients in this group will be undergoing total knee arthroplasty.

No interventions assigned to this group

Total Hip Arthroplasty

Patients in this group will be undergoing total hip arthroplasty.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consumer Sleep Solutions

UNKNOWN

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Michael Charters, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Charters, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Luke Wesemann

Role: CONTACT

801-499-1859

Facility Contacts

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Luke Wesemann

Role: primary

801-499-1859

References

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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.

Reference Type BACKGROUND
PMID: 8652329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28215264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2360740 (View on PubMed)

Other Identifiers

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13680

Identifier Type: -

Identifier Source: org_study_id

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