Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-05-18
Brief Title:
Sleep Patterns After Total Joint Replacement Surgery
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Sleep Patterns After Total Joint Replacement Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None