<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/NCT03303586</url>
  </required_header>
  <id_info>
    <org_study_id>16-5845-0</org_study_id>
    <nct_id>NCT03303586</nct_id>
  </id_info>
  <brief_title>Effects of Compression Stockings in Asthma Symptoms at Night</brief_title>
  <official_title>Investigating the Effects of Wearing Compression Stockings to Improve Asthma Symptoms at Night</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nocturnal worsening of asthma is common. It is characterized by overnight exacerbation of&#xD;
      asthma symptoms such as shortness of breath, chest tightness, coughing, and wheezing,&#xD;
      increased need of asthma medications and airway hyperresponsiveness, and decline in lung&#xD;
      function (1). Nocturnal asthma has been attributed in part to circadian variations in lung&#xD;
      function and airway inflammation. However, other factors including sleep, supine posture and&#xD;
      lung volume may also contribute to nocturnal asthma. Current treatments often improve&#xD;
      nighttime asthma symptoms. Nevertheless, nocturnal asthma is still common. Up to 2/3rd of&#xD;
      asthma patients report nocturnal asthma symptoms, and many asthma related events occur at&#xD;
      night, indicating poor asthma control. Results from an ongoing study suggest that in asthma&#xD;
      while subjects were supine, fluid shifted out of the legs and accumulated in the thorax&#xD;
      (rostral fluid shift) contributing to lower airway narrowing in asthma. A previou study has&#xD;
      shown that wearing compression stockings during the day reduces fluid retention in the legs,&#xD;
      reduces nocturnal rostral fluid shift out of the legs, and improves sleep apnea (2, 3). The&#xD;
      aims of the proposed study is investigate whether off-the-shelf, below the knee compression&#xD;
      stockings will attenuate nocturnal fluid shift and lower airway narrowing in asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2017</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to wearing compression stockings for next two weeks or not wearing compression stockings for next two weeks, and crossed over.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of wearing compression stockings on reducing rostral fluid shift during sleep and its effect in airway narrowing</measure>
    <time_frame>After 2 weeks of the intervention</time_frame>
    <description>Effect of wearing compression stockings or not on reducing fluid retention in the legs, reducing rostral fluid shift during sleep and improving nocturnal lower airway narrowing in asthma. After 2 weeks using or not compression stockings we will measure the overnight fluid volumes changes in leg, thorax and neck; changes in the respiratory impedance, pulmonary diffusion capacity and lung volume pre and post night of sleep</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Asthma group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compression Stockings</intervention_name>
    <description>We will use knee length, ready-made compression stockings at a pressure of 20-30mmHg at the ankle and if a good fit cannot be obtained, custom-made stockings will be ordered. Patients will be measured for compression stockings by a certified fitter.</description>
    <arm_group_label>Asthma group</arm_group_label>
    <arm_group_label>Healthy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will not wearing compression stockings for two weeks.</description>
    <arm_group_label>Asthma group</arm_group_label>
    <arm_group_label>Healthy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: non-smokers or former smokers (&lt;10 pack/year)&#xD;
&#xD;
        Exclusion Criteria: history of hypertension, or taking any prescribed medication for this&#xD;
        disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Azadeh Yadollahi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cristina O Francisco</last_name>
    <phone>416 597 3422</phone>
    <phone_ext>7656</phone_ext>
    <email>cristina.francisco@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Swati Bhatawadekar</last_name>
    <phone>416 597 3422</phone>
    <phone_ext>7729</phone_ext>
    <email>swati.bhatawadekar@uhn.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Toronto Rehabilitation Institute (TRI)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2A2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Francisco, PhD</last_name>
      <phone>416 597 3422</phone>
      <phone_ext>7656</phone_ext>
      <email>cristina.francisco@uhn.ca</email>
    </contact>
    <investigator>
      <last_name>Azadeh Yadollahi, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Skloot GS. Nocturnal asthma: mechanisms and management. Mt Sinai J Med. 2002 May;69(3):140-7.</citation>
    <PMID>12035073</PMID>
  </reference>
  <reference>
    <citation>Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.</citation>
    <PMID>21836140</PMID>
  </reference>
  <reference>
    <citation>White LH, Lyons OD, Yadollahi A, Ryan CM, Bradley TD. Effect of below-the-knee compression stockings on severity of obstructive sleep apnea. Sleep Med. 2015 Feb;16(2):258-64. doi: 10.1016/j.sleep.2014.12.005. Epub 2014 Dec 18.</citation>
    <PMID>25620198</PMID>
  </reference>
  <reference>
    <citation>Theriault L, Hermus G, Goldfarb D, Stonebridge C, Bounajm F. Cost Risk Analysis for Chronic Lung Disease in Canada. The Conference Board of Canada, 2012.</citation>
  </reference>
  <reference>
    <citation>Braido F, Baiardini I, Ghiglione V, Fassio O, Bordo A, Cauglia S, Canonica GW. Sleep disturbances and asthma control: a real life study. Asian Pac J Allergy Immunol. 2009 Mar;27(1):27-33.</citation>
    <PMID>19548627</PMID>
  </reference>
  <reference>
    <citation>Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med. 1988 Jul 29;85(1B):6-8. doi: 10.1016/0002-9343(88)90231-8.</citation>
    <PMID>3400687</PMID>
  </reference>
  <reference>
    <citation>Robertson CF, Rubinfeld AR, Bowes G. Deaths from asthma in Victoria: a 12-month survey. Med J Aust. 1990 May 21;152(10):511-7. doi: 10.5694/j.1326-5377.1990.tb125350.x.</citation>
    <PMID>2338923</PMID>
  </reference>
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    <citation>Yadollahi A, Singh B, Bradley TD. Investigating the Dynamics of Supine Fluid Redistribution Within Multiple Body Segments Between Men and Women. Ann Biomed Eng. 2015 Sep;43(9):2131-42. doi: 10.1007/s10439-015-1264-0. Epub 2015 Jan 30.</citation>
    <PMID>25632892</PMID>
  </reference>
  <reference>
    <citation>Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.</citation>
    <PMID>19240948</PMID>
  </reference>
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    <citation>Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.</citation>
    <PMID>10573240</PMID>
  </reference>
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    <citation>Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.</citation>
    <PMID>26378880</PMID>
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    <citation>Fredberg JJ, Wohl ME, Glass GM, Dorkin HL. Airway area by acoustic reflections measured at the mouth. J Appl Physiol Respir Environ Exerc Physiol. 1980 May;48(5):749-58. doi: 10.1152/jappl.1980.48.5.749.</citation>
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    <citation>Shiota S, Ryan CM, Chiu KL, Ruttanaumpawan P, Haight J, Arzt M, Floras JS, Chan C, Bradley TD. Alterations in upper airway cross-sectional area in response to lower body positive pressure in healthy subjects. Thorax. 2007 Oct;62(10):868-72. doi: 10.1136/thx.2006.071183. Epub 2007 Apr 18.</citation>
    <PMID>17442706</PMID>
  </reference>
  <reference>
    <citation>Bhatawadekar SA, Inman MD, Fredberg JJ, Tarlo SM, Lyons OD, Keller G, Yadollahi A. Contribution of rostral fluid shift to intrathoracic airway narrowing in asthma. J Appl Physiol (1985). 2017 Apr 1;122(4):809-816. doi: 10.1152/japplphysiol.00969.2016. Epub 2017 Jan 12.</citation>
    <PMID>28082337</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Azadeh Yadollahi</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Fluid Shift</keyword>
  <keyword>Compression stockings</keyword>
  <keyword>intrathoracic airway narrowing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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/NCT03303586
org study id: 16-5845-0
nct id: NCT03303586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nocturnal worsening of asthma is common. It is characterized by overnight exacerbation of
      asthma symptoms such as shortness of breath, chest tightness, coughing, and wheezing,
      increased need of asthma medications and airway hyperresponsiveness, and decline in lung
      function (1). Nocturnal asthma has been attributed in part to circadian variations in lung
      function and airway inflammation. However, other factors including sleep, supine posture and
      lung volume may also contribute to nocturnal asthma. Current treatments often improve
      nighttime asthma symptoms. Nevertheless, nocturnal asthma is still common. Up to 2/3rd of
      asthma patients report nocturnal asthma symptoms, and many asthma related events occur at
      night, indicating poor asthma control. Results from an ongoing study suggest that in asthma
      while subjects were supine, fluid shifted out of the legs and accumulated in the thorax
      (rostral fluid shift) contributing to lower airway narrowing in asthma. A previou study has
      shown that wearing compression stockings during the day reduces fluid retention in the legs,
      reduces nocturnal rostral fluid shift out of the legs, and improves sleep apnea (2, 3). The
      aims of the proposed study is investigate whether off-the-shelf, below the knee compression
      stockings will attenuate nocturnal fluid shift and lower airway narrowing in asthma.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will be randomly assigned to wearing compression stockings for next two weeks or not wearing compression stockings for next two weeks, and crossed over.
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of wearing compression stockings on reducing rostral fluid shift during sleep and its effect in airway narrowing
time frame: After 2 weeks of the intervention
description: Effect of wearing compression stockings or not on reducing fluid retention in the legs, reducing rostral fluid shift during sleep and improving nocturnal lower airway narrowing in asthma. After 2 weeks using or not compression stockings we will measure the overnight fluid volumes changes in leg, thorax and neck; changes in the respiratory impedance, pulmonary diffusion capacity and lung volume pre and post night of sleep
arm group label: Asthma group
arm group type: Active Comparator
description: Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.
arm group label: Healthy group
arm group type: Active Comparator
description: Participants will be randomized to wear compression stockings or to control group for two weeks and cross over in the end of the period. When assigned to wear compression stockings, they will be instructed to put the stockings on as soon as they get up in the morning and to remove them just prior to bedtime for two weeks. If they have become loose, a new pair will be fitted. They will be given a diary to record the time they put on and remove the compression stockings each day. They will be telephoned after one week to check the fit of the compression stockings.
intervention type: Other
intervention name: Compression Stockings
description: We will use knee length, ready-made compression stockings at a pressure of 20-30mmHg at the ankle and if a good fit cannot be obtained, custom-made stockings will be ordered. Patients will be measured for compression stockings by a certified fitter.
arm group label: Asthma group
arm group label: Healthy group
intervention type: Other
intervention name: Control
description: Participants will not wearing compression stockings for two weeks.
arm group label: Asthma group
arm group label: Healthy group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Azadeh Yadollahi
role: Principal Investigator
affiliation: Scientist
last name: Cristina O Francisco
phone: 416 597 3422
phone ext: 7656
email: cristina.francisco@uhn.ca
last name: Swati Bhatawadekar
phone: 416 597 3422
phone ext: 7729
email: swati.bhatawadekar@uhn.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
citation: Skloot GS. Nocturnal asthma: mechanisms and management. Mt Sinai J Med. 2002 May;69(3):140-7.
PMID: 12035073
citation: Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.
PMID: 21836140
citation: White LH, Lyons OD, Yadollahi A, Ryan CM, Bradley TD. Effect of below-the-knee compression stockings on severity of obstructive sleep apnea. Sleep Med. 2015 Feb;16(2):258-64. doi: 10.1016/j.sleep.2014.12.005. Epub 2014 Dec 18.
PMID: 25620198
citation: Theriault L, Hermus G, Goldfarb D, Stonebridge C, Bounajm F. Cost Risk Analysis for Chronic Lung Disease in Canada. The Conference Board of Canada, 2012.
citation: Braido F, Baiardini I, Ghiglione V, Fassio O, Bordo A, Cauglia S, Canonica GW. Sleep disturbances and asthma control: a real life study. Asian Pac J Allergy Immunol. 2009 Mar;27(1):27-33.
PMID: 19548627
citation: Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med. 1988 Jul 29;85(1B):6-8. doi: 10.1016/0002-9343(88)90231-8.
PMID: 3400687
citation: Robertson CF, Rubinfeld AR, Bowes G. Deaths from asthma in Victoria: a 12-month survey. Med J Aust. 1990 May 21;152(10):511-7. doi: 10.5694/j.1326-5377.1990.tb125350.x.
PMID: 2338923
citation: Yadollahi A, Singh B, Bradley TD. Investigating the Dynamics of Supine Fluid Redistribution Within Multiple Body Segments Between Men and Women. Ann Biomed Eng. 2015 Sep;43(9):2131-42. doi: 10.1007/s10439-015-1264-0. Epub 2015 Jan 30.
PMID: 25632892
citation: Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.
PMID: 19240948
citation: Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
PMID: 10573240
citation: Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.
PMID: 26378880
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responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Azadeh Yadollahi
investigator title: Scientist
mesh term: Asthma
sharing ipd: No