Atrial FibrillationNCT02916550
Breathing Intervention for Cardiac Anxiety
A study testing Breathing exercise in people with Atrial Fibrillation and Implantable Cardioverter Defibrillator, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Implantable Cardioverter Defibrillator
- What is being tested?
- Breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- BMI 17 to 35
- Proficient in English language
- Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions
Who cannot join
- No telephone access
- Active suicidal ideation with intent or plan
- Active drug or alcohol dependence, or active binge drinking within the last month
- Cardiovascular instability, as evidenced any of the following:
- New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken)
- American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care).
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- Unstable angina or exercise induced angina
- Persistent atrial fibrillation
- Pacemakers or combined pacemaker/ICDs will be excluded
- Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Anatomical and Psychophysiological Substrates of Interoception
This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.
Read the detailed description
Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.
- Being tested
- Breathing exercise
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseBehavioural
Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercise | Experimental | Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. Receives: Behavioral: Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac anxiety
Assessed via the Cardiac Anxiety Questionnaire
Measured: 1 month
Secondary outcomes (4)
Disability
Measured by the WHO Disability Assessment Scale (WHODAS)
Measured: 1 month
Wellbeing
NIH Patient Reported Outcome Measurement Information System (PROMIS)
Measured: 1 month
ICD anxiety
Florida Shock Anxiety Scale
Measured: 1 month
Arrhythmia burden
Presence of atrial fibrillation or ICD shocks
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2021
- Study completionMay 2023
Why it stopped: Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Sahib Khalsa, MD, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916550
- Sponsor's protocol ID
- Laureateinstitute
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2016
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Not IPD, just de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Psychophysiological Substrates of Interoception
- ClinicalTrials.gov ID
- NCT02916550
- Acronym / sponsor ID
- Laureateinstitute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- University of Arizona
- Study start
- Sep 2016
- Primary completion
- Sep 2021 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.
Detailed description
Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing exercise | Experimental | Behavioral: Breathing exerciseParticipants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80
- BMI 17 to 35
- Proficient in English language
- Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions
Key exclusion criteria (10 listed)
- No telephone access
- Active suicidal ideation with intent or plan
- Active drug or alcohol dependence, or active binge drinking within the last month
- Cardiovascular instability, as evidenced any of the following:
- Pacemakers or combined pacemaker/ICDs will be excluded
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 |
|---|---|---|
| Breathing exerciseParticipants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. | Behavioural | Breathing exercise |
Primary outcome
Cardiac anxiety
Time frame: 1 month
Assessed via the Cardiac Anxiety Questionnaire
4 secondary outcomes
Disability
Time frame: 1 month
Wellbeing
Time frame: 1 month
ICD anxiety
Time frame: 1 month
Arrhythmia burden
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: Yes. Not IPD, just de-identified data.
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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.
Sahib Khalsa, MD, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Atrial Fibrillation and Implantable Cardioverter Defibrillator, run by Laureate Institute for Brain Research, Inc. 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 10 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: stopped early, as of the sponsor's last update on 6 Oct 2023. 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?
The study was stopped early (reason given: Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.). Results are not available in the source record.
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?
Cardiac anxiety (time frame: 1 month). 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 6 Oct 2023.