Trial Outcomes & Findings for Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS) (NCT NCT02743520)
NCT ID: NCT02743520
Last Updated: 2020-11-19
Results Overview
New cases of atrial fibrillation as evaluated by the LifestarAct III.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Week 2
Results posted on
2020-11-19
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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86
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Overall Study
COMPLETED
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85
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Baseline characteristics by cohort
| Measure |
Cardiac Event Monitor
n=86 Participants
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.
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|---|---|
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Age, Continuous
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59.3 years
STANDARD_DEVIATION 9.1 • n=99 Participants
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Sex: Female, Male
Female
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46 Participants
n=99 Participants
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Sex: Female, Male
Male
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40 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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62 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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5 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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63 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Week 2New cases of atrial fibrillation as evaluated by the LifestarAct III.
Outcome measures
| Measure |
Cardiac Event Monitor
n=85 Participants
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.
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|---|---|
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Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
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2 Participants
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SECONDARY outcome
Timeframe: week 2More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Outcome measures
| Measure |
Cardiac Event Monitor
n=85 Participants
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.
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|---|---|
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Number of Participants With Frequent Ventricular Premature Contractions
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22 Participants
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SECONDARY outcome
Timeframe: Week 2Population: Due to software error, data could not be extracted for analysis for this outcome for all participants
Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 2Population: Due to software error, data could not be extracted for analysis for this outcome for all participants
In participants with atrial fibrillation as evaluated by the LifestarAct III.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 2More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Outcome measures
| Measure |
Cardiac Event Monitor
n=85 Participants
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.
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|---|---|
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The Number of Participants With Frequent Premature Atrial Contractions
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12 Participants
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Adverse Events
Cardiac Event Monitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alberto Ramos, MD, MSPH, FAASM
University of Miami, Miller School of Medicine
Phone: 305-243-8393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place