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Relationship Between PFTs and Pdi in DMD

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ClinicalTrials.gov Identifier: NCT03335384
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

October 12, 2017
November 7, 2017
November 7, 2017
December 2017
May 2019   (Final data collection date for primary outcome measure)
Evaluation of Pdi [ Time Frame: 1 year ]
For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons
Same as current
No Changes Posted
  • Evaluation of SNIP [ Time Frame: 1 year ]
    For all subjects, SNIP (sniff nasal inspiratory pressures) will be assessed with a nasal pressure transducer
  • Evaluation of FVC [ Time Frame: 1 year ]
    For all subjects, FVC (forced vital capacity) will be assessed with spirometry
  • Evaluation of FEV1 [ Time Frame: 1 year ]
    For all subjects, FEV1 (forced expiratory volume in 1 second) will be assessed with spirometry
  • Evaluation of FEFmax [ Time Frame: 1 year ]
    For all subjects, FEFmax (maximal forced expiratory flow) will be assessed with spirometry
  • Evaluation of FEF25-75 [ Time Frame: 1 year ]
    For all subjects, FEF25-75 (the average forced expiratory flow during the mid (25 - 75%) portion of the FVC) will be assessed with spirometry
  • Evaluation of FEF50 [ Time Frame: 1 year ]
    For all subjects, FEF50 (forced expiratory flow at 50% of FVC) will be assessed with spirometry
  • Evaluation of MIP [ Time Frame: 1 year ]
    For all subjects, MIP (maximal inspiratory pressure) will be assessed with spirometry
  • Evaluation of MEP [ Time Frame: 1 year ]
    For all subjects, MEP (maximal expiratory pressure) will be assessed with spirometry
Same as current
Not Provided
Not Provided
 
Relationship Between PFTs and Pdi in DMD
The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects
A cross-sectional study to explore the relationship between clinically assessed pulmonary function test (PFT) measures and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy (DMD) as well as to explore the relationship between sniff nasal inspiratory pressure (SNIP) and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy.
Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus and stomach through your nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. To reduce any discomfort with this procedure, lidocaine gel or spray will be put into the subject's nose and administered to the back of the throat before the balloon. In addition, swallowing water during the procedure will help to reduce any gagging sensation and will assure that the balloon goes into the esophagus. Proper placement of the catheters will be determined using normal tidal breathing against an occluded mouthpiece with a nose clip. Once proper placement is ensured, the catheters will remain in place during your normal PFT maneuvers. Additionally, while the gastric and esophageal balloon catheters are in place, the subject will be asked to perform a maximal sniff maneuver (SNIP) while one nostril is occluded with a plug containing a distal pressure measurement catheter to measure airway pressure. The distal end of the pressure catheter will be connected to a hand held pressure meter to display peak pressure and to provide you visual feedback. This maneuver will be performed 10 times.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cross-sectional
Masking: None (Open Label)
Primary Purpose: Health Services Research
Duchenne Muscular Dystrophy
  • Diagnostic Test: Esophageal Balloon
    Small flexible catheter with deflated balloon at distal end to be inserted into the esophagus through the nose
  • Diagnostic Test: Gastric Balloon
    Small flexible catheter with deflated balloon at distal end to be inserted into the stomach through the nose
  • Diagnostic Test: Nasal Pressure Transducer
    Pressure transducer inserted into nasal plug
  • Experimental: Measurement of Pdi
    Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus (food tube) and stomach through the nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. A gastric balloon will be inserted into subject's stomach while an esophageal balloon will be inserted into the subject's esophagus. To reduce any discomfort with this procedure, lidocaine gel or spray will be put into the subject's nose and administered to the back of the throat before the balloon. In addition, swallowing water during the procedure will help to reduce any gagging sensation and will assure that the balloon goes into the esophagus.
    Interventions:
    • Diagnostic Test: Esophageal Balloon
    • Diagnostic Test: Gastric Balloon
  • Experimental: Measurement of SNIPs
    While the gastric and esophageal balloon catheters are in place, the subject will be asked to perform a maximal sniff maneuver (SNIP) while one nostril is occluded with a plug containing a nasal pressure transducer to measure airway pressure during maximal inspiration. The distal end of the pressure catheter will be connected to a hand held pressure meter to display peak pressure and to provide you visual feedback. This maneuver will be performed 10 times.
    Intervention: Diagnostic Test: Nasal Pressure Transducer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
35
May 2019
May 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

  • Inability to follow verbal instructions
Sexes Eligible for Study: Male
6 Years to 25 Years   (Child, Adult)
No
Contact: Eli F Kelley, MS 320-290-0291 kelle833@d.umn.edu
Contact: Eric M Snyder, PhD 507-254-0723 snyd018@umn.edu
Not Provided
 
 
NCT03335384
STUDY00001062
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Fairview Health Services
Principal Investigator: Eric M Snyder, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP