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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02375087
First received: February 3, 2015
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
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

Condition
Myotonic Dystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from myotonic dystrophy (DM1)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02375087

Contacts
Contact: Jean Louis M PEPIN, Professor 33476765516 JPepin@chu-grenoble.fr
Contact: Amina Mrs FONTANELL, INGENEER 33476767662 lafontanell@chu-grenoble.fr

Locations
France
CHU Recruiting
Grenoble, France, 38000
Contact: Amina FONTANELL    33476767662    lafontanell@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02375087     History of Changes
Other Study ID Numbers: "STAR"
Study First Received: February 3, 2015
Last Updated: November 10, 2016

Additional relevant MeSH terms:
Myotonic Dystrophy
Muscular Dystrophies
Myotonic Disorders
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on March 22, 2017