Arrhythmia, Atrial Fibrillation, Stroke, Cardiovascular
Conditions
Keywords
sleep apnea, arrhythmia detection
Brief summary
The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats. The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).
Interventions
DEVICEThe Lifestar Act III
The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.
Sponsors
Boehringer Ingelheim
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of OSA within the last 12 months 2. No previous diagnosis of atrial fibrillation 3. Able and willing to follow-up as an outpatient 4. Age 40-85 years
Exclusion criteria
1. Life expectancy \< 2 years 2. Dementia or other neurologic condition which would make outpatient follow-up difficult 3. CHADS score \<2 4. Alcohol or drug abuse which would interfere with outpatient follow-up 5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device. 6. Current dialysis treatment or planned treatment within 12 months 7. Known bleeding disorder or prothrombin time \>15 seconds 8. Mechanical heart valve requiring anticoagulation 9. Moderate to severe mitral stenosis or regurgitation 10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded) 11. Chronic obstructive pulmonary disease with oxygen dependence 12. Pregnant patients or patients that plan to become pregnant within the course of the study\*. 13. Patients with anticipated need for a pacemaker during the course of the study \*If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) | Week 2 | New cases of atrial fibrillation as evaluated by the LifestarAct III. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Frequent Ventricular Premature Contractions | week 2 | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. |
| Longest Duration of Atrial Fibrillation | Week 2 | Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III. |
| Atrial Fibrillation Episodes Lasting More Than Six Minutes | Week 2 | In participants with atrial fibrillation as evaluated by the LifestarAct III. |
| The Number of Participants With Frequent Premature Atrial Contractions | Week 2 | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Event Monitor Participants will under go evaluation with a two week cardiac event monitor.
The Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings. | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cardiac Event Monitor |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
New cases of atrial fibrillation as evaluated by the LifestarAct III.
Time frame: Week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Event Monitor | Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) | 2 Participants |
Secondary
Atrial Fibrillation Episodes Lasting More Than Six Minutes
In participants with atrial fibrillation as evaluated by the LifestarAct III.
Time frame: Week 2
Population: Due to software error, data could not be extracted for analysis for this outcome for all participants
Secondary
Longest Duration of Atrial Fibrillation
Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.
Time frame: Week 2
Population: Due to software error, data could not be extracted for analysis for this outcome for all participants
Secondary
Number of Participants With Frequent Ventricular Premature Contractions
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Time frame: week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Event Monitor | Number of Participants With Frequent Ventricular Premature Contractions | 22 Participants |
Secondary
The Number of Participants With Frequent Premature Atrial Contractions
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Time frame: Week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Event Monitor | The Number of Participants With Frequent Premature Atrial Contractions | 12 Participants |