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Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years (Steinert)

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ClinicalTrials.gov Identifier: NCT03764150
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date November 19, 2018
First Posted Date December 4, 2018
Last Update Posted Date December 4, 2018
Actual Study Start Date June 30, 2010
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2018)
  • Change of measurement of spirometry [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation
  • Change respiratory force [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation to change Inspiratory and expiratory force
  • Change CO2 response (Read test) [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation
  • Change subjective sleepiness (Epworth) [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation
  • change Krupp's Fatigue Severity Scale (KFSS) [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation This is a short questionnaire of 9 questions to which the patient responds on a Likert scale ranging from 1 to 7
  • change cognitive impairment by Trail Making Test A & B [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
  • change Oximetry [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Official Title Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Brief Summary The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patient with a myotonic dystrophy of Steinert who consults in pneumology and who will have Respiratory functional exploration
Condition Myotonic Dystrophy, Steinert
Intervention Not Provided
Study Groups/Cohorts
  • PaCO2> 45 mmHg
    Diurnal hypercapnia defined by PaCO2> 45 mmHg
  • PaCO2 <45 mmHg
    PaCO2 diurnal within the limits of normal (PaCO2 <45 mmHg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 3, 2018)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Myotonic dystrophy of Steinert genetically confirmed (number of known CTG repeats), in its classical form of adult

Exclusion Criteria:

  • Inability to perform EFR assessment or polysomnography
  • Moderate to severe asthma according to the GINA classification
  • moderate to severe COPD (> stage 1 of the GOLD recommendations)
  • Other significant respiratory pathology
  • Patient already on NIV, CPAP or under oxygen therapy
  • Impossibility of receiving enlightened information
  • Inability to participate in the entire study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Thierry Perez, MD thierry.perez@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03764150
Other Study ID Numbers 2009_04/0923
2009-A00588-49 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Thierry Perez, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date December 2018