AsthmaNCT03303586
Effects of Compression Stockings in Asthma Symptoms at Night
A study testing Compression Stockings in people with Asthma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Compression Stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2017to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: non-smokers or former smokers (<10 pack/year)
Exclusion Criteria: uncontrolled hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute (TRI)
Toronto, Ontario, M5G 2A2
Cristina Francisco, PhD, 416 597 3422 ext. 7656, cristina.francisco@uhn.ca
Azadeh Yadollahi, PhD
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Compression Stockings, Control
- Keywords
- Asthma, Fluid Shift, Compression stockings, intrathoracic airway narrowing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression StockingsOther
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.
ControlOther
Participants will not wearing compression stockings for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Active comparator | 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. Receives: Other: Compression Stockings; Other: Control |
| Healthy group | Active comparator | 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. Receives: Other: Compression Stockings; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 2 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start21 Feb 2017
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azadeh Yadollahi, University Health Network, Toronto
- Investigators
- Azadeh Yadollahi, Principal investigator, Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303586
- Sponsor's protocol ID
- 16-5845-0
- Status last verified
- Feb 2025
- First submitted
- 2 Oct 2017
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skloot GS. Nocturnal asthma: mechanisms and management. Mt Sinai J Med. 2002 May;69(3):140-7.
PubMed 12035073Redolfi 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.
PubMed 21836140White 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.
PubMed 25620198Theriault L, Hermus G, Goldfarb D, Stonebridge C, Bounajm F. Cost Risk Analysis for Chronic Lung Disease in Canada. The Conference Board of Canada, 2012.
Braido F, Baiardini I, Ghiglione V, Fassio O, Bordo A, Cauglia S, Canonica GW. Sleep disturbances and asthma control: a real life study. Asian Pac J Allergy Immunol. 2009 Mar;27(1):27-33.
PubMed 19548627Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med. 1988 Jul 29;85(1B):6-8. doi: 10.1016/0002-9343(88)90231-8.
PubMed 3400687Robertson CF, Rubinfeld AR, Bowes G. Deaths from asthma in Victoria: a 12-month survey. Med J Aust. 1990 May 21;152(10):511-7. doi: 10.5694/j.1326-5377.1990.tb125350.x.
PubMed 2338923Yadollahi A, Singh B, Bradley TD. Investigating the Dynamics of Supine Fluid Redistribution Within Multiple Body Segments Between Men and Women. Ann Biomed Eng. 2015 Sep;43(9):2131-42. doi: 10.1007/s10439-015-1264-0. Epub 2015 Jan 30.
PubMed 25632892Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.
PubMed 19240948Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
PubMed 10573240Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.
PubMed 26378880Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
PubMed 10507956Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Chen MJ, Fan X, Moe ST. Criterion-related validity of the Borg ratings of perceived exertion scale in healthy individuals: a meta-analysis. J Sports Sci. 2002 Nov;20(11):873-99. doi: 10.1080/026404102320761787.
PubMed 12430990Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Wearing Compression Stockings to Improve Asthma Symptoms at Night
- ClinicalTrials.gov ID
- NCT03303586
- Acronym / sponsor ID
- 16-5845-0
- Conditions
- Asthma
- Keywords
- Asthma, Fluid Shift, Compression stockings, intrathoracic airway narrowing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Asthma group | Active comparator | Other: Compression Stockings, Other: ControlParticipants 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. |
| Healthy group | Active comparator | Other: Compression Stockings, Other: ControlParticipants 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression StockingsWe 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 | Asthma group, Healthy group |
| ControlParticipants will not wearing compression stockings for two weeks. | Other | Asthma group, Healthy group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 12035073Skloot GS. Nocturnal asthma: mechanisms and management. Mt Sinai J Med. 2002 May;69(3):140-7.
- Background: PubMed 21836140Redolfi 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.
- Background: PubMed 25620198White 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.
- BackgroundTheriault L, Hermus G, Goldfarb D, Stonebridge C, Bounajm F. Cost Risk Analysis for Chronic Lung Disease in Canada. The Conference Board of Canada, 2012.
- Background: PubMed 19548627Braido F, Baiardini I, Ghiglione V, Fassio O, Bordo A, Cauglia S, Canonica GW. Sleep disturbances and asthma control: a real life study. Asian Pac J Allergy Immunol. 2009 Mar;27(1):27-33.
- Background: PubMed 3400687Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med. 1988 Jul 29;85(1B):6-8. doi: 10.1016/0002-9343(88)90231-8.
- Background: PubMed 2338923Robertson CF, Rubinfeld AR, Bowes G. Deaths from asthma in Victoria: a 12-month survey. Med J Aust. 1990 May 21;152(10):511-7. doi: 10.5694/j.1326-5377.1990.tb125350.x.
- Background: PubMed 25632892Yadollahi A, Singh B, Bradley TD. Investigating the Dynamics of Supine Fluid Redistribution Within Multiple Body Segments Between Men and Women. Ann Biomed Eng. 2015 Sep;43(9):2131-42. doi: 10.1007/s10439-015-1264-0. Epub 2015 Jan 30.
- Background: PubMed 19240948Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.
- Background: PubMed 10573240Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
- Background: PubMed 26378880Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.
- Background: PubMed 10507956Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
- Individual participant dataSharing planned: No
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azadeh Yadollahi principal investigator
Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Stockings in people with Asthma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina O Francisco (416 597 3422 ext. 7656, cristina.francisco@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303586, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.