Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263757
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2005-12-07
Brief Title:
Atrial Fibrillation Recurrence in Sleep Apnea
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
This randomized controlled trial is designed to test whether treatment of sleep disordered breathing SDB with positive airway pressure PAP therapy alters the natural history of atrial fibrillation AF Patients with recent AF who are now in sinus rhythm and found to have SDB obstructive andor central sleep apnea by formal sleep study but without complaints of daytime sleepiness are randomized to PAP therapy to eradicate SDB or to usual care medical management as prescribed by the patients cardiologist
Detailed Description:
Sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease Observational data suggest that sleep apnea may play a role in the development of atrial fibrillation AF and may even predispose to recurrence of AF following electrical cardioversion DCCV Because of biases and confounders inherent to observational studies we propose a randomized clinical trial to assess the effects of treatment of sleep apnea in subjects with AF treated with DCCV Following polysomnography subjects with sleep apnea will be randomized to positive airway pressure PAP or usual medical care and followed for up to one year to compare a primary outcome of AF recurrence rate
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |
| 1RC1HL099534 | NIH | None | None |