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Effects of Compression Stockings in Asthma Symptoms at Night

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Compression Stockings
Control
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Fluid Shift, Compression stockings, intrathoracic airway narrowing

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Toronto Rehabilitation Institute (TRI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Asthma group

Healthy group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Effect of wearing compression stockings on reducing rostral fluid shift during sleep and its effect in airway narrowing
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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2017
Last Updated
October 6, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03303586
Brief Title
Effects of Compression Stockings in Asthma Symptoms at Night
Official Title
Investigating the Effects of Wearing Compression Stockings to Improve Asthma Symptoms at Night
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Anticipated)
Study Completion Date
November 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Fluid Shift, Compression stockings, intrathoracic airway narrowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asthma group
Arm Type
Active Comparator
Arm 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 Title
Healthy group
Arm Type
Active Comparator
Arm 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(s)
Compression Stockings
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will not wearing compression stockings for two weeks.
Primary Outcome Measure Information:
Title
Effect of wearing compression stockings on reducing rostral fluid shift during sleep and its effect in airway narrowing
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
Time Frame
After 2 weeks of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-smokers or former smokers (<10 pack/year) Exclusion Criteria: history of hypertension, or taking any prescribed medication for this disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina O Francisco
Phone
416 597 3422
Ext
7656
Email
cristina.francisco@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Swati Bhatawadekar
Phone
416 597 3422
Ext
7729
Email
swati.bhatawadekar@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azadeh Yadollahi
Organizational Affiliation
Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute (TRI)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Francisco, PhD
Phone
416 597 3422
Ext
7656
Email
cristina.francisco@uhn.ca
First Name & Middle Initial & Last Name & Degree
Azadeh Yadollahi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Compression Stockings in Asthma Symptoms at Night

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