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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

Study Description
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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.

Condition or disease
Myotonic Dystrophy, Steinert

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Actual Study Start Date : June 30, 2010
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
PaCO2> 45 mmHg
Diurnal hypercapnia defined by PaCO2> 45 mmHg
PaCO2 <45 mmHg
PaCO2 diurnal within the limits of normal (PaCO2 <45 mmHg)


Outcome Measures
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Primary Outcome Measures :
  1. Change of measurement of spirometry [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation

  2. Change respiratory force [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation to change Inspiratory and expiratory force

  3. Change CO2 response (Read test) [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation

  4. Change subjective sleepiness (Epworth) [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation

  5. 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

  6. 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.

  7. change Oximetry [ Time Frame: every year during 5 years ]
    composite predictive factors of alveolar hypoventilation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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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): NCT03764150


Contacts
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Contact: Thierry Perez, MD thierry.perez@chru-lille.fr

Locations
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France
Hôpital Calmette, CHRU Recruiting
Lille, France
Principal Investigator: Thierry Perez, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Thierry Perez, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03764150     History of Changes
Other Study ID Numbers: 2009_04/0923
2009-A00588-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Sleep Apnea Syndrome
Muscular Diseases
non invasive ventilation
Diaphragmatic Disorder
Additional relevant MeSH terms:
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Myotonic Dystrophy
Muscular Dystrophies
Myotonic Disorders
Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn