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Effects of Compression Stockings in Asthma Symptoms at Night

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ClinicalTrials.gov Identifier: NCT03303586
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Azadeh Yadollahi, University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Other: Compression Stockings Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effects of Wearing Compression Stockings to Improve Asthma Symptoms at Night
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Asthma group
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.
Other: Compression Stockings
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.

Other: Control
Participants will not wearing compression stockings for two weeks.

Active Comparator: Healthy group
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.
Other: Compression Stockings
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.

Other: Control
Participants will not wearing compression stockings for two weeks.




Primary Outcome Measures :
  1. 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 ]
    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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: non-smokers or former smokers (<10 pack/year)

Exclusion Criteria: history of hypertension, or taking any prescribed medication for this disorder.


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): NCT03303586


Contacts
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Contact: Cristina O Francisco 416 597 3422 ext 7656 cristina.francisco@uhn.ca
Contact: Swati Bhatawadekar 416 597 3422 ext 7729 swati.bhatawadekar@uhn.ca

Locations
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Canada, Ontario
Toronto Rehabilitation Institute (TRI) Recruiting
Toronto, Ontario, Canada, M5G 2A2
Contact: Cristina Francisco, PhD    416 597 3422 ext 7656    cristina.francisco@uhn.ca   
Principal Investigator: Azadeh Yadollahi, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Azadeh Yadollahi Scientist

Publications:
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.

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Responsible Party: Azadeh Yadollahi, Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03303586     History of Changes
Other Study ID Numbers: 16-5845-0
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Azadeh Yadollahi, University Health Network, Toronto:
Asthma
Fluid Shift
Compression stockings
intrathoracic airway narrowing

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases