Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ? (STAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02375087|
Recruitment Status : Recruiting
First Posted : March 2, 2015
Last Update Posted : November 11, 2016
|Condition or disease|
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|
|Estimated Enrollment :||70 participants|
|Official Title:||Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||September 2017|
- 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
- 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 ]
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): NCT02375087
|Contact: Jean Louis M PEPIN, Professor||33476765516||JPepin@chu-grenoble.fr|
|Contact: Amina Mrs FONTANELL, INGENEERemail@example.com|
|Grenoble, France, 38000|
|Contact: Amina FONTANELL 33476767662 firstname.lastname@example.org|