Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-06 @ 8:53 AM
Study NCT ID:
NCT03269760
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Sleep Pathway for Shoulder Arthroplasty
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2020-05
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 the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
Detailed Description:
Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the constraints of sling immobilization. While in the hospital, sleep is also disrupted due to pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial, sleep deprivation in animal models has identified significant adverse effects on bone metabolism, bone mass, and recovery from post surgical pain.
Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction.
The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction.
The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: