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Peak Cough Flow and Cough Clearance in Patients With Muscular Dystrophy

This study is currently recruiting participants.
Verified March 2017 by Daniel J. Weiner, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02034305
First Posted: January 13, 2014
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Respirtech, Inc.
Information provided by (Responsible Party):
Daniel J. Weiner, University of Pittsburgh
  Purpose
This study is to determine whether physiologic measures (peak cough flow, measures of respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous cough clearance (as measured by a nuclear medicine study) in children with neuromuscular disease. It will also determine whether airway clearance is augmented by high frequency chest wall oscillation.

Condition
Duchenne Muscular Dystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pilot Study of Cough Peak Flow And Airway Clearance in Pediatric Patients With Neuromuscular Disease

Resource links provided by NLM:


Further study details as provided by Daniel J. Weiner, University of Pittsburgh:

Primary Outcome Measures:
  • Spontaneous cough clearance [ Time Frame: Assessed at multiple time points over 30 minutes ]

Estimated Enrollment: 15
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Boys 6-21 years of age with Duchenne Muscular Dystrophy
Criteria

Inclusion Criteria:

  • Age 6-21; able to cooperate with study procedures
  • Duchenne Muscular Dystrophy OR Becker Muscular Dystrophy

Exclusion Criteria:

  • Need for mechanical ventilation during the day
  • Recent (within 2 weeks) lower respiratory tract infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034305


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Paul Rebovich, MS    412-692-5873    paul.rebovich@chp.edu   
Principal Investigator: Daniel J. Weiner, MD         
Sub-Investigator: Hoda Abdel-Hamid, MD         
Sub-Investigator: Timothy J Corcoran, PhD         
Sponsors and Collaborators
University of Pittsburgh
Respirtech, Inc.
  More Information

Responsible Party: Daniel J. Weiner, Associate Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02034305     History of Changes
Other Study ID Numbers: PRO11100704
First Submitted: January 9, 2014
First Posted: January 13, 2014
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Daniel J. Weiner, University of Pittsburgh:
Airway Clearance
Duchenne Muscular Dystrophy
Peak Cough Flow

Additional relevant MeSH terms:
Muscular Dystrophies
Cough
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Genetic Diseases, X-Linked