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

NCT02375087 | Completed

• 1 other identifier: "STAR"
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Myotonic Dystrophy

Outcome Measures

Primary Outcomes (1)

• Cardiac arythmia related to hypoxia and respiratory events

  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

  7days

Secondary Outcomes (4)

• A temporal link between Sleep desordered breathing events and the developpement of arrythmias

  7 days

• 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

  7 days

• To compare arrhythmias prevalence in REM and non REM sleep

  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

  7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from myotonic dystrophy (DM1)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: March 2, 2015
• Study Start: May 20, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

FR (1)