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

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Myotonic Dystrophy 1
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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.

Study Type

Observational

Primary Outcome

Change of measurement of spirometry

Condition

Myotonic Dystrophy, Steinert

Study Arms / Comparison Groups

 PaCO2> 45 mmHg
Description:  Diurnal hypercapnia defined by PaCO2> 45 mmHg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

160

Start Date

June 30, 2010

Completion Date

September 2023

Primary Completion Date

September 2023

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thierry Perez, MD, , [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT03764150

Organization ID

2009_04/0923

Secondary IDs

2009-A00588-49

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille

Study Sponsor

Thierry Perez, MD, Principal Investigator, University Hospital, Lille

Verification Date

January 2021