Atrial Fibrillation Recurrence in Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT00263757|
Recruitment Status : Completed
First Posted : December 9, 2005
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Atrial Fibrillation||Device: Adaptive Servo-Ventilation Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Therapeutic Positive Airway Pressure
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
Device: Adaptive Servo-Ventilation
Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.
Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Other: Usual Care
Subjects randomized to this arm received medical management as prescribed by their cardiologist.
- Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year [ Time Frame: 1 year ]
- Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit [ Time Frame: baseline, 12 months ]The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).
- Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: baseline, 12 months ]The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263757
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sean M. Caples, D.O.||Mayo Clinic|