Atrial Fibrillation, Sleep Apnea
Conditions
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 and/or 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 patient's 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.
Interventions
Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.
OTHERUsual Care
Subjects randomized to this arm received medical management as prescribed by their cardiologist.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
ResMed Foundation
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 yrs 2. Successful electrical or chemical cardioversion within previous 2 weeks 3. Greater than 2 episodes symptomatic AF in previous 6 months
Exclusion criteria
1. Currently on PAP therapy 2. Moderate to severe pulmonary disease 3. Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis) 4. Severe cardiac disease (LVEF\<40%, greater than mild to moderate valvular disease) 5. Post cardiac surgery AF 6. Congenital heart disease 7. Renal disease (Scr \> 2.5) 8. Excessive ethanol (EtOH) use (\>2 drinks/day) 9. Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis) 10. History of motor vehicle or occupational accident related to sleepiness. 11. Epworth Sleepiness Scale score \>18 (out of maximum score of 24).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | 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) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Therapeutic Positive Airway Pressure Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months. | 12 |
| Usual Care Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist. | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Screen failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Therapeutic Positive Airway Pressure | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 3 / 13 |
| serious Total, serious adverse events | 1 / 12 | 2 / 13 |
Outcome results
Primary
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Therapeutic Positive Airway Pressure | Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year | 3 participants |
| Usual Care | Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year | 3 participants |
Secondary
Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit
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).
Time frame: baseline, 12 months
Population: Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapeutic Positive Airway Pressure | Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | Baseline Visit, n=12, 13 | 4.75 units on a scale | Standard Deviation 2.14 |
| Therapeutic Positive Airway Pressure | Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | 12 Month Visit, n=5, 6 | 5.80 units on a scale | Standard Deviation 2.59 |
| Usual Care | Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | Baseline Visit, n=12, 13 | 7.31 units on a scale | Standard Deviation 3.33 |
| Usual Care | Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | 12 Month Visit, n=5, 6 | 5.67 units on a scale | Standard Deviation 2.34 |
Secondary
Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)
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).
Time frame: baseline, 12 months
Population: Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapeutic Positive Airway Pressure | Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) | Baseline visit, n=12, 13 | 19.08 units on a scale | Standard Deviation 0.67 |
| Therapeutic Positive Airway Pressure | Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) | 12 months visit, n=4, 4 | 18.25 units on a scale | Standard Deviation 1.5 |
| Usual Care | Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) | Baseline visit, n=12, 13 | 17.62 units on a scale | Standard Deviation 1.56 |
| Usual Care | Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) | 12 months visit, n=4, 4 | 17.50 units on a scale | Standard Deviation 1.91 |