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Multimodal Sleep Pathway for Shoulder Arthroplasty

Primary Purpose

Sleep Disturbance, Shoulder Arthritis, Arthroplasty Complications

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zolpidem
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All consenting adults undergoing elective total shoulder replacement

-

Exclusion Criteria:

  • Allergies to zolpidem or refusal to participate in study

Sites / Locations

  • Ucsf

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Interventional Sleep Medicine

Arm Description

Current practice of postoperative care without sleep medicine measures

Use of a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem to improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Outcomes

Primary Outcome Measures

Lead's Sleep scale
Patient reported outcome

Secondary Outcome Measures

Sleep journals
patient reported outcome
Pain scores
]pain scores

Full Information

First Posted
August 30, 2017
Last Updated
May 26, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03269760
Brief Title
Multimodal Sleep Pathway for Shoulder Arthroplasty
Official Title
Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Shoulder Arthritis, Arthroplasty Complications, Perioperative/Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Current practice of postoperative care without sleep medicine measures
Arm Title
Interventional Sleep Medicine
Arm Type
Experimental
Arm Description
Use of a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem to improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Other Intervention Name(s)
Nursing sleep medicine protocol
Intervention Description
Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency
Primary Outcome Measure Information:
Title
Lead's Sleep scale
Description
Patient reported outcome
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Sleep journals
Description
patient reported outcome
Time Frame
postoperative day 1-7
Title
Pain scores
Description
]pain scores
Time Frame
postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All consenting adults undergoing elective total shoulder replacement - Exclusion Criteria: Allergies to zolpidem or refusal to participate in study
Facility Information:
Facility Name
Ucsf
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25837184
Citation
Cho CH, Lee SW, Lee YK, Shin HK, Hwang I. Effect of a sleep aid in analgesia after arthroscopic rotator cuff repair. Yonsei Med J. 2015 May;56(3):772-7. doi: 10.3349/ymj.2015.56.3.772.
Results Reference
background
PubMed Identifier
24074687
Citation
Chouchou F, Khoury S, Chauny JM, Denis R, Lavigne GJ. Postoperative sleep disruptions: a potential catalyst of acute pain? Sleep Med Rev. 2014 Jun;18(3):273-82. doi: 10.1016/j.smrv.2013.07.002. Epub 2013 Sep 24.
Results Reference
background
PubMed Identifier
26909151
Citation
Dolan R, Huh J, Tiwari N, Sproat T, Camilleri-Brennan J. A prospective analysis of sleep deprivation and disturbance in surgical patients. Ann Med Surg (Lond). 2016 Jan 6;6:1-5. doi: 10.1016/j.amsu.2015.12.046. eCollection 2016 Mar.
Results Reference
background
PubMed Identifier
26344094
Citation
Gong L, Wang Z, Fan D. Sleep Quality Effects Recovery After Total Knee Arthroplasty (TKA)--A Randomized, Double-Blind, Controlled Study. J Arthroplasty. 2015 Nov;30(11):1897-901. doi: 10.1016/j.arth.2015.02.020. Epub 2015 Feb 24.
Results Reference
background
PubMed Identifier
24634631
Citation
Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
Results Reference
background
PubMed Identifier
22831887
Citation
Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
Results Reference
background
PubMed Identifier
21731144
Citation
Mah CD, Mah KE, Kezirian EJ, Dement WC. The effects of sleep extension on the athletic performance of collegiate basketball players. Sleep. 2011 Jul 1;34(7):943-50. doi: 10.5665/SLEEP.1132.
Results Reference
background
PubMed Identifier
25842028
Citation
Mulligan EP, Brunette M, Shirley Z, Khazzam M. Sleep quality and nocturnal pain in patients with shoulder disorders. J Shoulder Elbow Surg. 2015 Sep;24(9):1452-7. doi: 10.1016/j.jse.2015.02.013. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
21253706
Citation
Tompkins M, Plante M, Monchik K, Fleming B, Fadale P. The use of a non-benzodiazepine hypnotic sleep-aid (Zolpidem) in patients undergoing ACL reconstruction: a randomized controlled clinical trial. Knee Surg Sports Traumatol Arthrosc. 2011 May;19(5):787-91. doi: 10.1007/s00167-010-1368-x. Epub 2011 Jan 21.
Results Reference
background
PubMed Identifier
26342649
Citation
Wang PK, Cao J, Wang H, Liang L, Zhang J, Lutz BM, Shieh KR, Bekker A, Tao YX. Short-Term Sleep Disturbance-Induced Stress Does not Affect Basal Pain Perception, but Does Delay Postsurgical Pain Recovery. J Pain. 2015 Nov;16(11):1186-99. doi: 10.1016/j.jpain.2015.07.006. Epub 2015 Sep 3.
Results Reference
background
PubMed Identifier
27485745
Citation
Xu X, Wang L, Chen L, Su T, Zhang Y, Wang T, Ma W, Yang F, Zhai W, Xie Y, Li D, Chen Q, Fu X, Ma Y, Zhang Y. Effects of chronic sleep deprivation on bone mass and bone metabolism in rats. J Orthop Surg Res. 2016 Aug 2;11(1):87. doi: 10.1186/s13018-016-0418-6.
Results Reference
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Multimodal Sleep Pathway for Shoulder Arthroplasty

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