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
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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