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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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).

Sponsor: University Hospital, Grenoble

Current Primary Outcome: Cardiac arythmia related to hypoxia and respiratory events [ Time Frame: 7days ]

Ambulatory at home concurrent assessment of arrhythmias and sleep breathing disorders by a multi-modal ECG Holter (Vista O2; Novacor, Rueil Malmaison, FranceTM). We will record seven consecutive nights at home to increase the sensitivity and the number of abnormal rhythmic events available for analysis. One night full polysomnography followed by Multiple sleep latency tests


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • A temporal link between Sleep desordered breathing events and the developpement of arrythmias [ Time Frame: 7 days ]
    More specifically the occurrence of arrhythmias will be correlated with the severity of oxygen desaturation
  • To assess during the entire night the increase in sympathetic activity (LF/HF ratio) in response to abnormal respiratory events during sleep and the relationship between sympathetic activity and prevalence of arrhythmias [ Time Frame: 7 days ]
  • To compare arrhythmias prevalence in REM and non REM sleep [ Time Frame: 7 days ]
  • To see whether a high adherence to non invasive ventilation (>6hours/night) and the suppression of oxygen desaturation is associated with a lower prevalence of arrhythmias [ Time Frame: 7 days ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: February 3, 2015
Date Started: May 2014
Date Completion: September 2017
Last Updated: November 10, 2016
Last Verified: November 2016