Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?

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Brief Title

Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?

Official Title

Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?

Brief Summary

      Up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from
      arrhythmias. Sleep apnea is prevalent in myotonic dystrophy (DM1) patients. Among the serious
      complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac death
      (SCD). Diagnosis of sleep apnea using simple tools in ambulatory cardiology practice may
      improve therapy of cardiac arrhythmias in patients with DM1
    

Detailed Description

      Obstructive sleep apnea (OSA) and central sleep apnea (CSA), the most common form of sleep
      disordered breathing (SDB), are prevalent in patients with myotonic dystrophy type 1 (DM1).
      Among the serious complications from sleep apnea, the most alarming are cardiovascular,
      including arrhythmias and sudden cardiac death (SCD). Diagnosis of SDB using simple tools in
      ambulatory cardiology practice may lead to an important primary or additional therapy to
      supplement the use of drugs or devices in the treatment of cardiac arrhythmias.

      We hypothesize that DM1 patients with severe oxygen desaturations (Oxygen desaturation index
      >15/hour of sleep and/or cumulative time spent below 90% of SaO2 above 5% of time of
      recording) will exhibit three fold more nocturnal arrhythmias compared to DM1 group without
      oxygen desaturations during sleep.

      During this project we will address the following aims:

        -  Is there a relationship between the severity of oxygen desaturations during sleep and
           nocturnal arrhythmias? We will address this question in a prospective study with seven
           nights of at home recordings with a multimodal holter EKG assessing together
           arrhythmias, thoracic impedance (in order to estimate respiratory movements) and SaO2.

        -  The specific proarrhythmic role of REM sleep will be assessed during a single night full
           polysomnography and multiple sleep latency tests (MSLT).
    


Study Type

Observational


Primary Outcome

Cardiac arythmia related to hypoxia and respiratory events

Secondary Outcome

 A temporal link between Sleep desordered breathing events and the developpement of arrythmias

Condition

Myotonic Dystrophy



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

73

Start Date

May 20, 2014

Completion Date

July 1, 2017

Primary Completion Date

July 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients suffering from myotonic dystrophy (DM1)

          -  DM1 patients participating in the clinical cohorts of Grenoble, Saint-Etienne and
             Montpellier.

          -  Patients implanted or not with pacing devices or cardioverter-defibrillator (ICD).

          -  Patients treated or not by non invasive ventilation (NIV) at home. As a majority, of
             the patients with DM1 are poorly adherent with NIV they continue to exhibit
             significant desaturation during night. Truly compliant patients (mean daily
             duration>6/h night) will be studied as a predefined subgroup to assess the protective
             effect of NIV for suppressing oxygen desaturations and avoiding occurrence of
             nocturnal arrhythmias.

        Exclusion Criteria:

          -  Patients who have had an acute episode of respiratory failure in the previous month

          -  Incapacitated patients in accordance with article L 1121-6 of the public health code
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02375087

Organization ID

"STAR"


Responsible Party

Sponsor

Study Sponsor

University Hospital, Grenoble


Study Sponsor

, , 


Verification Date

January 2020