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

• ClinicalTrials.gov Identifier: NCT02375087
• Recruitment Status: Completed
• First Posted: March 2, 2015
• Last Update Posted: January 18, 2020
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Tracking Information

• First Submitted Date: February 3, 2015
• First Posted Date: March 2, 2015
• Last Update Posted Date: January 18, 2020
• Actual Study Start Date: May 20, 2014
• Actual Primary Completion Date: July 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2015)

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 Measures: Same as current

Current Secondary Outcome Measures (submitted: February 23, 2015)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients suffering from myotonic dystrophy (DM1)
• Condition: Myotonic Dystrophy
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 16, 2020): 73
• Original Estimated Enrollment (submitted: February 23, 2015): 70
• Actual Study Completion Date: July 1, 2017
• Actual Primary Completion Date: July 1, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02375087
• Other Study ID Numbers: "STAR"
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Grenoble
• Study Sponsor: University Hospital, Grenoble
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Grenoble
• Verification Date: January 2020