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

Liberate Medical

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Device: Abdominal Stimulation - low/full

Device: Abdominal Stimulation - high/full

Device: Abdominal Stimulation - low / early

Device: Abdominal Stimulation - high/late

Device: Abdominal stimulation - med/late

Device: Abdominal Stimulation - high/early

Device: Abdominal stimulation - low/late

Device: Abdominal stimulation - med/early

Device: Abdominal Stimulation - med/full

Study type

Interventional

Funder types

Industry

Identifiers

NCT02035228

LM-SB-001

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Seated

Experimental group

Description:

Patients breathing will be compared across a series of 9 trials in which unassisted breathing is compared to abdominal stimulation (SecondBreath) assisted breathing at various intensities. Each breathing trial will last for 2 minutes and will be conducted while the patient is seated. The following abdominal stimulation trials were included: Abdominal Stimulation - low / early Abdominal stimulation - low/late Abdominal Stimulation - low/full Abdominal stimulation - med/early Abdominal stimulation - med/late Abdominal Stimulation - med/full Abdominal Stimulation - high/early Abdominal Stimulation - high/late Abdominal Stimulation - high/full

Treatment: