Effects of Compression Stockings in Asthma Symptoms at Night

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03303586
• Other study ID #: 16-5845-0
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 6, 2017
• Start date: February 21, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: October 2017
• Source: University Health Network, Toronto
• Contact: Cristina O Francisco
• Phone: 416 597 3422
• Email: cristina.francisco[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Control
Participants will not wearing compression stockings for two weeks.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute (TRI)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After 2 weeks of the intervention