Effects of Compression Stockings in Asthma Symptoms at Night

NCT ID: NCT03303586

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Compression Stockings

Intervention Type OTHER

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

Intervention Type OTHER

Participants will not wearing compression stockings for two weeks.

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.

Group Type ACTIVE_COMPARATOR

Compression Stockings

Intervention Type OTHER

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

Intervention Type OTHER

Participants will not wearing compression stockings for two weeks.

Interventions

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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.

Intervention Type OTHER

Control

Participants will not wearing compression stockings for two weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria: uncontrolled hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Azadeh Yadollahi

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azadeh Yadollahi

Role: PRINCIPAL_INVESTIGATOR

Scientist

Locations

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Toronto Rehabilitation Institute (TRI)

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Cristina O Francisco

Role: CONTACT

416 597 3422 ext. 7656

Facility Contacts

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Cristina Francisco, PhD

Role: primary

416 597 3422 ext. 7656

References

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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.

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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.

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Other Identifiers

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16-5845-0

Identifier Type: -

Identifier Source: org_study_id

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