Recruiting

Compression Stockings

Sponsor:

University Health Network, Toronto

Code:

NCT03303586

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Compression Stockings

Control

Study Details

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.

Conditions

Asthma

Study ID

NCT03303586

Start date

Feb 21, 2017

Status verified date

Feb, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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

Exclusion Criteria: uncontrolled hypertension

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Control

Participants will not wearing compression stockings for two weeks.

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

Locations

Toronto Rehabilitation Institute (TRI)

Recruiting

Toronto, Ontario, Canada, M5G 2A2

Contacts

Principal Investigator:

Azadeh Yadollahi, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2025

Last verified

Feb, 2025

Keywords

  • Asthma
  • Fluid Shift
  • Compression stockings
  • intrathoracic airway narrowing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-03-05.