Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT02916550
Status:
TERMINATED
Last Update Posted:
2023-10-06
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breathing Intervention for Cardiac Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac anxiety', 'timeFrame': '1 month', 'description': 'Assessed via the Cardiac Anxiety Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '1 month', 'description': 'Measured by the WHO Disability Assessment Scale (WHODAS)'}, {'measure': 'Wellbeing', 'timeFrame': '1 month', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS)'}, {'measure': 'ICD anxiety', 'timeFrame': '1 month', 'description': 'Florida Shock Anxiety Scale'}, {'measure': 'Arrhythmia burden', 'timeFrame': '1 month', 'description': 'Presence of atrial fibrillation or ICD shocks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Implantable Cardioverter Defibrillator']}, 'descriptionModule': {'briefSummary': 'This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 80\n* BMI 17 to 35\n* Proficient in English language\n* Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions\n\nExclusion Criteria:\n\n* No telephone access\n* Active suicidal ideation with intent or plan\n* Active drug or alcohol dependence, or active binge drinking within the last month\n* Cardiovascular instability, as evidenced any of the following:\n\n 1. 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)\n 2. American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care).\n 3. Unstable angina or exercise induced angina\n 4. Persistent atrial fibrillation\n* Pacemakers or combined pacemaker/ICDs will be excluded\n* 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.'}, 'identificationModule': {'nctId': 'NCT02916550', 'briefTitle': 'Breathing Intervention for Cardiac Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Laureate Institute for Brain Research, Inc.'}, 'officialTitle': 'Anatomical and Psychophysiological Substrates of Interoception', 'orgStudyIdInfo': {'id': 'Laureateinstitute'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breathing exercise', 'description': 'Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.', 'interventionNames': ['Behavioral: Breathing exercise']}], 'interventions': [{'name': 'Breathing exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.', 'armGroupLabels': ['Breathing exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Laureate Institute for Brain Research', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Sahib Khalsa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laureate Institute for Brain Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Not IPD, just de-identified data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laureate Institute for Brain Research, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arizona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}