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

NCT ID: NCT03764150

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2023-06-11

Brief Summary

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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

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Conditions

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Myotonic Dystrophy, Steinert

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PaCO2> 45 mmHg

Diurnal hypercapnia defined by PaCO2\> 45 mmHg

No interventions assigned to this group

PaCO2 <45 mmHg

PaCO2 diurnal within the limits of normal (PaCO2 \<45 mmHg)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Perez, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Centre Hospitalier Regional D' Angers

Angers, , France

Site Status

Ap-Hp Hu Paris Site Raymond Poincare

Garches, , France

Site Status

Hôpital Calmette, CHRU

Lille, , France

Site Status

Chu Montpellier

Montpellier, , France

Site Status

Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1

Nantes, , France

Site Status

Ap-Hp Hu Pitie Salpetriere

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00588-49

Identifier Type: OTHER

Identifier Source: secondary_id

2009_04/0923

Identifier Type: -

Identifier Source: org_study_id

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