Atrial FibrillationADIOSNCT02743520
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
A study testing The Lifestar Act III in people with Atrial Fibrillation and Arrhythmia, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia, Stroke, Cardiovascular
- What is being tested?
- The Lifestar Act III
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OSA within the last 12 months
- No previous diagnosis of atrial fibrillation
- Able and willing to follow-up as an outpatient
- Age 40-85 years
Who cannot join
- Life expectancy < 2 years
- Dementia or other neurologic condition which would make outpatient follow-up difficult
- CHADS score <2
- Alcohol or drug abuse which would interfere with outpatient follow-up
- Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
- Current dialysis treatment or planned treatment within 12 months
Show all 13Show fewer
- Known bleeding disorder or prothrombin time >15 seconds
- Mechanical heart valve requiring anticoagulation
- Moderate to severe mitral stenosis or regurgitation
- Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)
- Chronic obstructive pulmonary disease with oxygen dependence
- Pregnant patients or patients that plan to become pregnant within the course of the study*.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea
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).
- Conditions
- Atrial Fibrillation, Arrhythmia, Stroke, Cardiovascular
- Being tested
- The Lifestar Act III
- Keywords
- sleep apnea, arrhythmia detection
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Myocardial Infarction, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lifestar Act IIIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac event monitor | Experimental | Participants will under go evaluation with a two week cardiac event monitor. Receives: Device: The Lifestar Act III |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2
Secondary outcomes (4)
Number of Participants With Frequent Ventricular Premature Contractions
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Measured: week 2
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.
Measured: Week 2
Atrial Fibrillation Episodes Lasting More Than Six Minutes
In participants with atrial fibrillation as evaluated by the LifestarAct III.
Measured: 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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start6 Mar 2017
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Alberto Rafael Ramos, University of Miami
- Investigators
- Alberto R Ramos, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743520
- Sponsor's protocol ID
- 20150860
- Acronym
- ADIOS
- Status last verified
- Oct 2020
- First submitted
- 14 Apr 2016
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02743520
- Acronym / sponsor ID
- ADIOS / 20150860
- Conditions
- Atrial Fibrillation, Arrhythmia, Stroke, Cardiovascular
- Keywords
- sleep apnea, arrhythmia detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac event monitor | Experimental | Device: The Lifestar Act IIIParticipants will under go evaluation with a two week cardiac event monitor. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of OSA within the last 12 months
- No previous diagnosis of atrial fibrillation
- Able and willing to follow-up as an outpatient
- Age 40-85 years
Key exclusion criteria (13 listed)
- Life expectancy < 2 years
- Dementia or other neurologic condition which would make outpatient follow-up difficult
- CHADS score <2
- Alcohol or drug abuse which would interfere with outpatient follow-up
- Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Lifestar Act IIIThe 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. | Device | Cardiac event monitor |
Primary outcome
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
Time frame: Week 2
New cases of atrial fibrillation as evaluated by the LifestarAct III.
4 secondary outcomes
Number of Participants With Frequent Ventricular Premature Contractions
Time frame: week 2
Longest Duration of Atrial Fibrillation
Time frame: Week 2
Atrial Fibrillation Episodes Lasting More Than Six Minutes
Time frame: Week 2
The Number of Participants With Frequent Premature Atrial Contractions
Time frame: Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto R Ramos, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lifestar Act III in people with Atrial Fibrillation and Arrhythmia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.