Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT03235466
Status:
UNKNOWN
Last Update Posted:
2020-12-04
First Post:
2017-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial of Behavioral Therapy for Chronic Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-12', 'releaseDate': '2022-07-04'}], 'estimatedResultsFirstSubmitDate': '2022-07-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial of 3 groups: 1) standard voice therapy 2) voice therapy and heart rate variability biofeedback and 3) heart rate variability biofeedback'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2017-07-15', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Cough reduction', 'timeFrame': '3 weeks', 'description': 'Measured by changes in cough severity index and patient recordings'}], 'secondaryOutcomes': [{'measure': 'Durability of cough remediation', 'timeFrame': '8 weeks', 'description': 'Phone call to patients'}, {'measure': 'Changes in dyspnea', 'timeFrame': '3 weeks', 'description': 'Measured by dyspnea index'}, {'measure': 'Change in voice', 'timeFrame': '3 weeks', 'description': 'Measured by voice handicap index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. Several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. Additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. HRV biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. By using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device\n\nExclusion Criteria:\n\n* On neuromodulator therapy, cardiac arrhythmia, dysphagia, prior HRVB or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ACE inhibitor use, current or recent smoker.\n\nAdded exclusion criteria as of March 2020 - history of COVID+.'}, 'identificationModule': {'nctId': 'NCT03235466', 'briefTitle': 'A Prospective Trial of Behavioral Therapy for Chronic Cough', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Prospective Trial of Behavioral Therapy for Chronic Cough', 'orgStudyIdInfo': {'id': '181207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Voice Therapy', 'description': '(Group 1) will undergo active training in behavioral cough suppression and laryngeal relaxation exercises, but will not receive HRVB. Traditional cough suppression and laryngeal relaxation exercises include pursed lip breathing, swallowing (water, lozenge, gum, ice chips), sustained semi-occluded voicing, discussion and mitigation of triggers, maintaining a cough journal, addressing muscle tension dysphonia if indicated, and developing prophylaxis suppression and laryngeal relaxation based on stimulability. Participants in Group 1 will receive handwritten guidance indicating exercises to practice at home.', 'interventionNames': ['Behavioral: Voice Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voice Therapy and Heart Rate Variability Biofeedback', 'description': 'Voice therapy as described in Arm 1. HRVB involves measure respiratory rate, heart rate, body temperature and skin conductance. Participants are guided through reduced breathing rate until a resonant frequency is attained. HRVB breathing simulates resonance between the baroreflex rhythm and respiration based rhythm, increasing heart rate variability and baroreceptor sensitivity. Evidence suggests HRVB improves autonomic regularity. We propose this novel modality to address centrally regulated hypersensitivity that perpetuates coughing.', 'interventionNames': ['Behavioral: Voice Therapy and Heart Rate Variability Biofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heart Rate Variability Biofeedback', 'description': 'HRVB as indicated in Arm 2. No instruction will be provided for cough suppression, laryngeal desensitization, voice tasks or hygiene that traditionally reduces cough frequency and severity. This is the experimental arm.', 'interventionNames': ['Behavioral: Heart Rate Variability Biofeedback']}], 'interventions': [{'name': 'Voice Therapy', 'type': 'BEHAVIORAL', 'description': 'See Arm 1 \\& 2', 'armGroupLabels': ['Voice Therapy']}, {'name': 'Voice Therapy and Heart Rate Variability Biofeedback', 'type': 'BEHAVIORAL', 'description': 'See Arm 2 \\& 3', 'armGroupLabels': ['Voice Therapy and Heart Rate Variability Biofeedback']}, {'name': 'Heart Rate Variability Biofeedback', 'type': 'BEHAVIORAL', 'description': 'See Arm 2 \\& 3', 'armGroupLabels': ['Heart Rate Variability Biofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92122', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Philip Weissbrod, MD', 'role': 'CONTACT', 'email': 'pweissbrod@ucsd.edu', 'phone': '858-657-8590'}, {'name': 'Erin Walsh, MA', 'role': 'CONTACT', 'email': 'ehwalsh@ucsd.edu', 'phone': '8586578590'}], 'facility': 'UCSD Center for Voice and Swallowing', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Philip Weissbrod, MD', 'role': 'CONTACT', 'email': 'pweissbrod@ucsd.edu', 'phone': '858-657-8590'}, {'name': 'Erin Walsh, MA', 'role': 'CONTACT', 'email': 'ehwalsh@ucsd.edu', 'phone': '858-657-8590'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Voice and Swallowing', 'investigatorFullName': 'Philip Weissbrod', 'investigatorAffiliation': 'University of California, San Diego'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-04', 'type': 'RELEASE'}, {'date': '2023-05-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Philip Weissbrod, Director, Center for Voice and Swallowing, University of California, San Diego'}}}}