Evaluation of Muscle Activation Efficiency in Challenging Subjects

Not Applicable

Completed

• Conditions: COPD; Obesity

• Registration Number: NCT01811446
• Lead Sponsor: Niveus Medical, Inc.

Brief Summary

The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• BMI > 30 (Wing 1 of study)
• Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)

Exclusion Criteria

• Age < 18 years
• Subject has an implanted pacemaker/defibrillator
• Subject diagnosed with epilepsy
• Subject has implanted metallic femoral rods
• Subject is chair- or bed-bound
• Subject has neuromuscular disease or abnormalities
• Subject BMI > 45
• Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intensity Required	During treatment	Intensity required to achieve target levels of muscle contraction

Secondary Outcome Measures

Name	Time	Method
Comfort	During treatment	Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale

Trial Locations

Locations (1)

Fogarty Clinical Research; 🇺🇸 Mountain View, California, United States