<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/NCT02242708</url>
  </required_header>
  <id_info>
    <org_study_id>1010807</org_study_id>
    <nct_id>NCT02242708</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing</brief_title>
  <official_title>The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative&#xD;
      nostril breathing to improve life quality, autonomic nervous system and immune status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise&#xD;
      can regulate autonomic nervous function and promote relaxation. However, the mechanism for&#xD;
      better immunity and sleep quality is not clear. We postulate that alternative nostril&#xD;
      breathing might benefit nurses after undergoing shift work. The benefits could be due to&#xD;
      improvement of autonomic nervous function, sleep quality, and even immune function.&#xD;
&#xD;
      The study design will include a randomization of two groups, with a control group and one&#xD;
      experimental groups for 3 months (12 weeks). The control group will do normal breathing. The&#xD;
      experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for&#xD;
      3 months.&#xD;
&#xD;
      The study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep&#xD;
      quality and 3) to enhance human immunity.&#xD;
&#xD;
      We anticipate to reach the primary endpoints and publish the primary results in one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improve sleep quality.</measure>
    <time_frame>Change from baseline in sleep quality at 3 months.</time_frame>
    <description>Sleep quality will be assessed by pittsburg sleep quality index at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enhance human immunity</measure>
    <time_frame>Change from baseline in human immunity at 3 months.</time_frame>
    <description>Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation, polarization and its related cytokines. Saliva will be collected at 3 different times: (1)baseline data: before alternate nostril breathing program ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improve autonomic nervous function</measure>
    <time_frame>Change from baseline in autonomic nervous function at 3 months.</time_frame>
    <description>Autonomic nervous function will be assessed by biofeedback index using heart rate variability at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Shift Nurses</condition>
  <arm_group>
    <arm_group_label>Normal breathing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will do normal breathing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alternative nostril breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alternative nostril breathing</intervention_name>
    <description>The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.</description>
    <arm_group_label>Alternative nostril breathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Shift nurses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper respiratory tract infection such as nasal congestion, runny nose, coughing,&#xD;
             wheezing, nosebleeds, fever and other symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuender D. Yang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming-Ho Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kuender D. Yang, PhD</last_name>
    <phone>886-975617006</phone>
    <email>yehshuhui@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ming-Ho Lee</investigator_full_name>
    <investigator_title>MD.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02242708
org study id: 1010807
nct id: NCT02242708
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative
      nostril breathing to improve life quality, autonomic nervous system and immune status.
Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise
      can regulate autonomic nervous function and promote relaxation. However, the mechanism for
      better immunity and sleep quality is not clear. We postulate that alternative nostril
      breathing might benefit nurses after undergoing shift work. The benefits could be due to
      improvement of autonomic nervous function, sleep quality, and even immune function.

      The study design will include a randomization of two groups, with a control group and one
      experimental groups for 3 months (12 weeks). The control group will do normal breathing. The
      experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for
      3 months.

      The study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep
      quality and 3) to enhance human immunity.

      We anticipate to reach the primary endpoints and publish the primary results in one year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Improve sleep quality.
time frame: Change from baseline in sleep quality at 3 months.
description: Sleep quality will be assessed by pittsburg sleep quality index at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
measure: Enhance human immunity
time frame: Change from baseline in human immunity at 3 months.
description: Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation, polarization and its related cytokines. Saliva will be collected at 3 different times: (1)baseline data: before alternate nostril breathing program ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
measure: Improve autonomic nervous function
time frame: Change from baseline in autonomic nervous function at 3 months.
description: Autonomic nervous function will be assessed by biofeedback index using heart rate variability at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
arm group label: Normal breathing
arm group type: No Intervention
description: The control group will do normal breathing.
arm group label: Alternative nostril breathing
arm group type: Experimental
description: The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
intervention type: Behavioral
intervention name: Alternative nostril breathing
description: The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
arm group label: Alternative nostril breathing
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kuender D. Yang, PhD
role: Study Director
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Ming-Ho Lee
role: Principal Investigator
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Kuender D. Yang, PhD
phone: 886-975617006
email: yehshuhui@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Ming-Ho Lee
investigator title: MD.