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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac event monitor | Experimental | Participants will under go evaluation with a two week cardiac event monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Lifestar Act III | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Frequent Ventricular Premature Contractions | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. | week 2 |
| Longest Duration of Atrial Fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto R Ramos, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Week 2 |
|
Two weeks
Only intervention related adverse events were collected for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Ramos, MD, MSPH, FAASM | University of Miami, Miller School of Medicine | 305-243-8393 | a.ramos1@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Oct 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D009203 | Myocardial Infarction |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.
| Week 2 |
| Atrial Fibrillation Episodes Lasting More Than Six Minutes | In participants with atrial fibrillation as evaluated by the LifestarAct III. | Week 2 |
| The Number of Participants With Frequent Premature Atrial Contractions | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. | Week 2 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| 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. | Posted | Count of Participants | Participants | week 2 |
|
|
|
| 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. | Due to software error, data could not be extracted for analysis for this outcome for all participants | Posted | Week 2 |
|
|
| Secondary | Atrial Fibrillation Episodes Lasting More Than Six Minutes | In participants with atrial fibrillation as evaluated by the LifestarAct III. | Due to software error, data could not be extracted for analysis for this outcome for all participants | Posted | Week 2 |
|
|
| 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. | Posted | Count of Participants | Participants | Week 2 |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
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| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |