Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients

Completed · Not applicable

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

This is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. As part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.

Key facts

Study ID

NCT02035228

Run by

Liberate Medical

People needed

7

Starts

2013-03-01

Expected to finish

2014-01-01

Last updated by the study team

2018-08-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Post-bronchodilator FEV1/FVC ratio of less than 0.7 and post-bronchodilator FEV1 between 30 and 80 % predicted.
• Current or former smokers with at least a 20 pack year smoking history
• Over the age of forty

You may not qualify if…

• Female subjects who are pregnant
• Subjects unable to give informed consent
• Subjects unable to perform required activities of the study (e.g. Six minute walk test)
• Subjects with an implanted electronic device (e.g. a cardiac pacemaker)
• Subjects who have had a chronic obstructive pulmonary disease exacerbation within 30 days prior to enrollment
• Considerable arthritic changes that limit exertion
• Patients on oral prednisone
• Patients with a hernia
• Patients with a history of pneumothorax within the last 5 years
• History of epilepsy
• History of Abnormal electrocardiogram suggestive of cardiac disease

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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