Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02375087
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-02-03
Brief Title:
Sleep Breathing Disorders a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Sleep Breathing Disorders a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
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 15hour of sleep andor 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
We hypothesize that DM1 patients with severe oxygen desaturations Oxygen desaturation index 15hour of sleep andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None