Effects of Compression Stockings in Asthma Symptoms At Night

February 28, 2025 updated by: Azadeh Yadollahi, University Health Network, Toronto

Investigating the Effects of Wearing Compression Stockings to Improve Asthma Symptoms At Night

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Recruiting
        • Toronto Rehabilitation Institute (TRI)
        • Contact:
        • Contact:
          • Azadeh Yadollahi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria: uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 2 weeks of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Azadeh Yadollahi, Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5845-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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