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Trial record 58 of 120 for:    ZOLPIDEM AND AIDS

Multimodal Sleep Pathway for Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT03269760
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Shoulder Arthritis Arthroplasty Complications Perioperative/Postoperative Complications Drug: Zolpidem Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Current practice of postoperative care without sleep medicine measures
Experimental: Interventional Sleep Medicine
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.
Drug: Zolpidem
Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency
Other Name: Nursing sleep medicine protocol




Primary Outcome Measures :
  1. Lead's Sleep scale [ Time Frame: postoperative day 1 ]
    Patient reported outcome


Secondary Outcome Measures :
  1. Sleep journals [ Time Frame: postoperative day 1-7 ]
    patient reported outcome

  2. Pain scores [ Time Frame: postoperative day 1 ]
    ]pain scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All consenting adults undergoing elective total shoulder replacement

-

Exclusion Criteria:

  • Allergies to zolpidem or refusal to participate in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269760


Contacts
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Contact: Jonathan Cheah, MD 4154766548 jonathan.cheah@ucsf.edu
Contact: Alan Zhang, MD 4153532808 alan.zhang@ucsf.edu

Locations
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United States, California
Ucsf Recruiting
San Francisco, California, United States, 94143
Contact: Jonathan Cheah, MD    415-476-6548    jonathan.cheah@ucsf.edu   
Contact: Alan Zhang    4153532808    alan.zhang@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03269760     History of Changes
Other Study ID Numbers: 16-20346
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Zolpidem
Sleep Aids, Pharmaceutical
Dyssomnias
Sleep Wake Disorders
Parasomnias
Postoperative Complications
Pathologic Processes
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action