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Completed

NCT Number: NCT02035228

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Stimulation - low / early

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at low stimulation current for the first half of exhalation

Other names: SecondBreath

Abdominal stimulation - low/late

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at low stimulation current for the second half of exhalation

Other names: SecondBreath

Abdominal Stimulation - low/full

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at low stimulation current throughout exhalation

Other names: SecondBreath

Abdominal stimulation - med/early

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at medium stimulation current for the first half of exhalation

Other names: SecondBreath

Abdominal stimulation - med/late

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at medium stimulation current for the second half of exhalation

Other names: SecondBreath

Abdominal Stimulation - med/full

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at medium stimulation current throughout exhalation

Other names: SecondBreath

Abdominal Stimulation - high/early

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at high stimulation current for the first half of exhalation

Other names: SecondBreath

Abdominal Stimulation - high/late

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at hig stimulation current for the second half of exhalation

Other names: SecondBreath

Abdominal Stimulation - high/full

Device

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.

Stimulation is applied at high stimulation current throughout exhalation

Other names: SecondBreath

Primary outcomes

  1. Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated

    Time frame: 2 minutes

    Inspiratory Capacity was measured before and after two minute periods of volitional and abdominal stimulation assisted breathing. The two minute trials of breathing were measured while patients were seated.

  2. Change in inspiratory capacity during a 6 minute step test

    Time frame: 6 minutes

Secondary outcomes

  1. Average tidal volume during 2 minutes of resting breathing while seated

    Time frame: 2 minutes

  2. Average minute ventilation during 2 minutes of resting breathing while seated

    Time frame: 2 minutes

  3. Average peak expiratory flow rate during 2 minutes of resting breathing while seated

    Time frame: 2 minutes

  4. Average breathing rate during two minutes of resting breathing while seated

    Time frame: 2 minutes

  5. Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test

    Time frame: 6 minutes

Sponsors and collaborators

Lead sponsor

Liberate Medical

Industry

Registry information

Official study title

Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2014
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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