Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03335384
Other study ID # STUDY00001062
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date May 2018

Study information

Verified date May 2018
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Male
Age group 6 Years to 25 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

- Inability to follow verbal instructions

Study Design


Intervention

Diagnostic Test:
Esophageal Balloon
Small flexible catheter with deflated balloon at distal end to be inserted into the esophagus through the nose
Gastric Balloon
Small flexible catheter with deflated balloon at distal end to be inserted into the stomach through the nose
Nasal Pressure Transducer
Pressure transducer inserted into nasal plug

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute Fairview Health Services

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Pdi For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons 1 year
Secondary Evaluation of SNIP For all subjects, SNIP (sniff nasal inspiratory pressures) will be assessed with a nasal pressure transducer 1 year
Secondary Evaluation of FVC For all subjects, FVC (forced vital capacity) will be assessed with spirometry 1 year
Secondary Evaluation of FEV1 For all subjects, FEV1 (forced expiratory volume in 1 second) will be assessed with spirometry 1 year
Secondary Evaluation of FEFmax For all subjects, FEFmax (maximal forced expiratory flow) will be assessed with spirometry 1 year
Secondary Evaluation of FEF25-75 For all subjects, FEF25-75 (the average forced expiratory flow during the mid (25 - 75%) portion of the FVC) will be assessed with spirometry 1 year
Secondary Evaluation of FEF50 For all subjects, FEF50 (forced expiratory flow at 50% of FVC) will be assessed with spirometry 1 year
Secondary Evaluation of MIP For all subjects, MIP (maximal inspiratory pressure) will be assessed with spirometry 1 year
Secondary Evaluation of MEP For all subjects, MEP (maximal expiratory pressure) will be assessed with spirometry 1 year
See also
  Status Clinical Trial Phase
Completed NCT05575648 - Dual Task in Duchenne Muscular Dystrophy N/A
Terminated NCT03907072 - Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2/Phase 3
Not yet recruiting NCT06450639 - An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy Phase 2
Completed NCT04335942 - Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor N/A
Active, not recruiting NCT04906460 - Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53) Phase 1/Phase 2
Active, not recruiting NCT02500381 - Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD) Phase 3
Enrolling by invitation NCT05967351 - A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study Phase 3
Recruiting NCT03067831 - Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy Phase 1/Phase 2
Recruiting NCT01834040 - Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy Phase 1/Phase 2
Completed NCT02246478 - A Study of TAS-205 for Duchenne Muscular Dystrophy Phase 1
Active, not recruiting NCT01772043 - Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping N/A
Terminated NCT01168908 - Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy Phase 2
Completed NCT00758225 - Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Phase 2
Completed NCT03680365 - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Recruiting NCT03513367 - The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.
Recruiting NCT05712447 - Duchenne Muscular Dystrophy Video Assessment Registry
Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Completed NCT03319030 - Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)
Terminated NCT01753804 - A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy. N/A
Completed NCT02530905 - Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients Phase 1