<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03269760</url>
  </required_header>
  <id_info>
    <org_study_id>16-20346</org_study_id>
    <nct_id>NCT03269760</nct_id>
  </id_info>
  <brief_title>Multimodal Sleep Pathway for Shoulder Arthroplasty</brief_title>
  <official_title>Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of&#xD;
      orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal&#xD;
      sleep pathway including non-pharmacological sleep hygiene interventions and the use of&#xD;
      zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing&#xD;
      total shoulder arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep&#xD;
      disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the&#xD;
      constraints of sling immobilization. While in the hospital, sleep is also disrupted due to&#xD;
      pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial,&#xD;
      sleep deprivation in animal models has identified significant adverse effects on bone&#xD;
      metabolism, bone mass, and recovery from post surgical pain.&#xD;
&#xD;
      Recent evidence has shown that non-pharmacological sleep interventions that improve sleep&#xD;
      hygiene and duration can optimize athletic peak performance, fatigue, and recovery.&#xD;
      Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative&#xD;
      patients has suggested safe administration, improved pain control, reduced pain medication&#xD;
      use, and higher patient satisfaction in the settings of total knee and hip arthroplasty,&#xD;
      rotator cuff repairs, and ACL reconstruction.&#xD;
&#xD;
      The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of&#xD;
      orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal&#xD;
      sleep pathway including non-pharmacological sleep hygiene interventions and the use of&#xD;
      zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing&#xD;
      total shoulder arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lead's Sleep scale</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>Patient reported outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep journals</measure>
    <time_frame>postoperative day 1-7</time_frame>
    <description>patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>]pain scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Shoulder Arthritis</condition>
  <condition>Arthroplasty Complications</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Current practice of postoperative care without sleep medicine measures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventional Sleep Medicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zolpidem</intervention_name>
    <description>Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency</description>
    <arm_group_label>Interventional Sleep Medicine</arm_group_label>
    <other_name>Nursing sleep medicine protocol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All consenting adults undergoing elective total shoulder replacement&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to zolpidem or refusal to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ucsf</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25837184</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24074687</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26909151</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26344094</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24634631</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22831887</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21731144</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25842028</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21253706</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26342649</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27485745</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zolpidem</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03269760
org study id: 16-20346
nct id: NCT03269760
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lead's Sleep scale
time frame: postoperative day 1
description: Patient reported outcome
measure: Sleep journals
time frame: postoperative day 1-7
description: patient reported outcome
measure: Pain scores
time frame: postoperative day 1
description: ]pain scores
arm group label: Control
arm group type: No Intervention
description: Current practice of postoperative care without sleep medicine measures
arm group label: Interventional Sleep Medicine
arm group type: Experimental
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: Zolpidem
description: Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency
arm group label: Interventional Sleep Medicine
other name: Nursing sleep medicine protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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.
PMID: 25837184
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.
PMID: 24074687
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.
PMID: 26909151
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.
PMID: 26344094
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.
PMID: 24634631
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.
PMID: 22831887
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.
PMID: 21731144
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.
PMID: 25842028
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.
PMID: 21253706
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.
PMID: 26342649
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.
PMID: 27485745
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Postoperative Complications
mesh term: Zolpidem
sharing ipd: No